No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00814247020727 | VPBB15014100 | BoogieBaby nasal aspirator – standard tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip with cover | ||
2 | 00814247020680 | VPBB15011100 | BoogieBaby nasal aspirator – preemie tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip | ||
3 | 00814247020444 | ROM-6000 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Collection Kit | |
4 | 30814247020346 | PRS-0530 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai | ||
5 | 00814247020147 | DSD-2000 | ClearView accessory - Disposable Sound Dilator | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView | |
6 | 00814247020130 | DSD-1000 | Sound/Dilator (accessory for ClearView Uterine Manipulator) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView | ||
7 | 00814247021083 | VPBB150112100 | BoogieBaby nasal aspirator – olive tip 4.5 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch long | ||
8 | 00814247020734 | VPBB15015100 | BoogieBaby nasal aspirator – flair tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – flair tip | ||
9 | 00814247020697 | VPBB15012100 | BoogieBaby nasal aspirator – preemie tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip with cover | ||
10 | 00814247020468 | ROM-QCS | ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Strip Quality Control | |
11 | 00814247020604 | UM900 | ClearView Uterine Manipulator, 9cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
12 | 00814247020482 | UM202 | ClearView Uterine Manipulator, long tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
13 | 00814247020475 | UM201 | ClearView Uterine Manipulator, regular tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
14 | 00814247021090 | VPBB150113100 | BoogieBaby nasal aspirator – olive tip 3.25 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 3.25 inch long | ||
15 | 00814247020857 | ROM-6025 | ROM Plus Cassette/Collection Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus, Quality Control for Fetal Membranes Rupture Tes | |
16 | 00814247020451 | ROM-QC | ROM Plus®, Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Quality Control Kit | |
17 | 00814247020284 | KDT-1000 | Koala Toco® Single-Use Tocodyamometer | HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | Koala Toco® | |
18 | 00814247020017 | UM700 | ClearView Uterine Manipulator, 7cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
19 | 00814247020666 | VAC-6000S | Kiwi® Vacuum Delivery System ProCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® ProCup® | |
20 | 00814247021106 | VPBB150114100 | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | ||
21 | 00814247020802 | PRS-EVAL | Traxi Panniculus Retractor with Retentus Technology | CCX | Support, Patient Position | traxi® Panniculus Retractor | ||
22 | 00814247020345 | PRS-1030 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor | |
23 | 00814247020659 | VAC-6000MTE | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
24 | 00814247020642 | VAC-6000MT | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
25 | 00814247020635 | VAC-6000ME | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
26 | 00814247020628 | VAC-6000C | Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® Omni-C Cup® | |
27 | 00814247020499 | UM750 | ClearView Total Uterine Manipulator, regular tip (7cm) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView Total Uterine Manipulator | ||
28 | 00814247020710 | VPBB15013100 | BoogieBaby nasal aspirator – standard tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip | ||
29 | 00814247020437 | ROM-5025 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
30 | 00814247020420 | ROM-5000 | ROM Plus® Complete Test Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
31 | 00814247020406 | ROM-1025 | ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | ROM Plus®, Fetal Membranes Rupture Test | ||
32 | 00814247020093 | CIRC-1350 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
33 | 00814247020079 | CIRC-1300 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
34 | 00814247020055 | CIRC-1150 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
35 | 00814247020031 | CIRC-1100 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | AccuCirc® | ||
36 | 00814247020000 | VAC-6000M | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
37 | 00814247020369 | PRS-1050 | Traxi Extender (BMI>50 - used with PH-25) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor Extender | |
38 | 00814247020277 | IPC-5090 | Cables to IUP catheters: Edan F6 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
39 | 00814247020260 | IPC-5080 | Cables to IUP catheters: Philips Avalon | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
40 | 00814247020253 | IPC-5061 | Cables to IUP catheters | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
41 | 00814247020246 | IPC-5060 | Cables to IUP catheters: Neoventa | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
42 | 00814247020239 | IPC-5050 | Cables to IUP catheters: Space Labs Medical 94000 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
43 | 00814247020222 | IPC-5018 | Cables to IUP catheters: HP8040A 40mV | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
44 | 00814247020215 | IPC-5016 | Cables to IUP catheters: Litton Air-Shields Fetascan 1400 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
45 | 00814247020208 | IPC-5014 | Cables to IUP catheters: GE Coro 115/116/118 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
46 | 00814247020192 | IPC-5012 | Cables to IUP catheters: HP8040A 5mV/1350 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
47 | 30814247020360 | PRS-0550 | Traxi Extender with Retentus Technology (BMI>50 - used with PH-25) | CCX | Support, Patient Position | traxi® Panniculus Retractor Extender | ||
48 | 00814247020598 | SBT-7019 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
49 | 00814247020581 | SBT-7018 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
50 | 00814247020574 | SBT-7017 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | H671MIS50ST0 | Integrated Stylet | MIS-50ST | Saline/Contrast Media Infusion Catheter, 5 Fr. with Integrated Stylet | TVUS/HSG-Cath | UTAH MEDICAL PRODUCTS, INC. |
2 | H671MIS50P0 | Peel-Away Introducer | MIS-50P | Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer | TVUS/HSG-Cath | UTAH MEDICAL PRODUCTS, INC. |
3 | H671MIS1000 | Uterine Manipulator | MIS-100 | Laparoscopic Uterine Manipulator-INjector | LUMIN | UTAH MEDICAL PRODUCTS, INC. |
4 | 05051223000600 | PS3111 | PS3111 | The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Inject The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Injector with application in Diagnostic Laparoscopy, Minilaparotomy, Fertility Examinations and salpingoplastics. | Uterine Manipulator / Injector 4,5mm | PURPLE SURGICAL INTERNATIONAL LIMITED |
5 | 04715309125236 | UMI 4.5KC | "Manipulator is a simple, safe and effective device for Diagnostic Laparosco "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff." | NA | PANPAC MEDICAL CORPORATION | |
6 | 04715309125229 | UMI 4.5C | "Manipulator is a simple, safe and effective device for Diagnostic Laparosco "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff." | NA | PANPAC MEDICAL CORPORATION | |
7 | 04715309125205 | UMI 4.5K | "Manipulator is a simple, safe and effective device for Diagnostic Laparosco "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff." | NA | PANPAC MEDICAL CORPORATION | |
8 | 04715309125199 | UMI 4.5 | Manipulator is a simple, safe and effective device for Diagnostic Laparoscop Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff. | NA | PANPAC MEDICAL CORPORATION | |
9 | 04715309125182 | UIC5FAX | The catheter is to be used for sonohysterography procedure that aid in the analy The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use. | NA | PANPAC MEDICAL CORPORATION | |
10 | 04715309125151 | UIC5FA | The catheter is to be used for sonohysterography procedure that aid in the analy The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use. | NA | PANPAC MEDICAL CORPORATION | |
11 | 04715309125144 | UI 2.0 | Uterine Injectors are double lumen, slightly curved and designed for single use. Uterine Injectors are double lumen, slightly curved and designed for single use. It was developed to facilitate diagnostic procedures such as Laparoscopy, Minilaps, Salpingoplasties and Fertility Examinations. It is a sterile disposable product consisting of plastic tube, connector and other plastic components which meets the USP recommendation for class VI testing. | NA | PANPAC MEDICAL CORPORATION | |
12 | 04715309125137 | UI 4.0 | Uterine Injectors are double lumen, slightly curved and designed for single use. Uterine Injectors are double lumen, slightly curved and designed for single use. It was developed to facilitate diagnostic procedures such as Laparoscopy, Minilaps, Salpingoplasties and Fertility Examinations. It is a sterile disposable product consisting of plastic tube, connector and other plastic components which meets the USP recommendation for class VI testing. | NA | PANPAC MEDICAL CORPORATION | |
13 | 04715309125120 | BA071F | HSG catheter sets can be used for sonohysterography and hysterosalpingography pr HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only. | NA | PANPAC MEDICAL CORPORATION | |
14 | 04715309125113 | BA051F | HSG catheter sets can be used for sonohysterography and hysterosalpingography pr HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only. | NA | PANPAC MEDICAL CORPORATION | |
15 | 04715309125069 | UIC5F | The catheter is to be used for sonohysterography procedure that aid in the analy The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use. | NA | PANPAC MEDICAL CORPORATION | |
16 | 04715309125052 | BA07F | HSG catheter sets can be used for sonohysterography and hysterosalpingography pr HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only. | NA | PANPAC MEDICAL CORPORATION | |
17 | 04715309125045 | BA05F | HSG catheter sets can be used for sonohysterography and hysterosalpingography pr HSG catheter sets can be used for sonohysterography and hysterosalpingography procedures that greatly enhance the analysis of uterine pathology. Using HSG balloon catheters, the procedures are simple and non-traumatic for your patients. A placement sheath eliminates the need for a tenaculum. HSG catheters are designed for single patient use only. | NA | PANPAC MEDICAL CORPORATION | |
18 | 04715309122914 | UMI 4.5KC-D | "Manipulator is a simple, safe and effective device for Diagnostic Laparosco "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff." | The O.R. Company LLC | PANPAC MEDICAL CORPORATION | |
19 | 04715309122891 | UMI 4.5C-D | "Manipulator is a simple, safe and effective device for Diagnostic Laparosco "Manipulator is a simple, safe and effective device for Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty. It also helps the sealing of the cervical as while providing a fluid or air to the cuff." | The O.R. Company LLC | PANPAC MEDICAL CORPORATION | |
20 | 04713025224004 | BA05F-S | HSG catheters may be used to evaluate the causes of abnormal uterine bleeding, m HSG catheters may be used to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurrent pregnancy loss or unexplained infertility. These devices are also very useful for the assessment of uterine pathology and assessment of patients on tamoxifen therapy. | NA | PANPAC MEDICAL CORPORATION | |
21 | GYNX101601 | 10-160 | Century Uterine Manipulator | GYNEX CORPORATION | ||
22 | 04038653042449 | ER876 | ER876 | Uterine Irrigation Cannula with two interchangeable cones, 13 3/4", (350 mm), no Uterine Irrigation Cannula with two interchangeable cones, 13 3/4", (350 mm), non-sterile, reusable | AESCULAP | AESCULAP AG |
23 | 00888937019957 | AU-AD-DLNTR | Sterile drape | Ally UPS Adapter Drape for Advincula Delineator | COOPERSURGICAL, INC. | |
24 | 00888937016567 | 19611 | GyneCath Catheter • 7F for Hysterosonography and Hysterosalpingography | GyneCath Catheter • 7F | COOPERSURGICAL, INC. | |
25 | 00888937016550 | 19610 | GyneCath Catheter • 5F for Hysterosonography and Hysterosalpingography | GyneCath Catheter • 5F | COOPERSURGICAL, INC. | |
26 | 00888937016390 | 61-2005 | Tampa Catheter for Hysterosonography 5 French • 33 cm Long | Tampa Catheter for Hysterosonography | COOPERSURGICAL, INC. | |
27 | 00888937015836 | AU-UPS | ALLY Uterine Positioning System® | ALLY Uterine Positioning System® | COOPERSURGICAL, INC. | |
28 | 00888937014174 | ABBI | ABBI™ (Air Bubble Based Infuser) For office based Sono HSG Procedures | ABBI | COOPERSURGICAL, INC. | |
29 | 00888937013634 | ZSI1152 | ZUI 4.0™ Uterine Injector O.D.: 4.0 mm • Length: 23 cm (9") | ZUI | COOPERSURGICAL, INC. | |
30 | 00888937013313 | ZSI1153 | ZUI 2.0™ Uterine Injector O.D.: 2.0 mm • Length: 23 cm (9") | ZUI | COOPERSURGICAL, INC. | |
31 | 00888937013221 | ZSI1151 | ZUMI 4.5™ Uterine Manipulator-Injector O.D.: 4.5 mm • Length: 33 cm (13") | ZUMI | COOPERSURGICAL, INC. | |
32 | 00888937001457 | UMY514 | Disposable Uterine Manipulator Tip; Tip Diameter 5.1mm | The RUMI System | COOPERSURGICAL, INC. | |
33 | 00888937001440 | UMW676 | Disposable Uterine Manipulator Tip; Tip Diameter 6.7mm | The RUMI System | COOPERSURGICAL, INC. | |
34 | 00888937001433 | UMO672 | Disposable Uterine Manipulator Tip; Tip Diameter 6.7mm | The RUMI System | COOPERSURGICAL, INC. | |
35 | 00888937001426 | UML516 | Disposable Uterine Manipulator Tip; Tip Diameter 5.1mm | The RUMI System | COOPERSURGICAL, INC. | |
36 | 00888937001419 | UMG670 | Disposable Uterine Manipulator Tip; Tip Diameter 6.7mm | The RUMI System | COOPERSURGICAL, INC. | |
37 | 00888937001402 | UMB678 | Disposable Uterine Manipulator Tip; Tip Diameter 6.7mm | The RUMI System | COOPERSURGICAL, INC. | |
38 | 00886333005741 | 660005000 | 660005000 | HSG Procedure Tray 5.5F | HSG Procedure Tray | ARGON MEDICAL DEVICES, INC. |
39 | 00886333005734 | 660007000 | 660007000 | HSG Procedure Tray 7F | HSG Procedure Tray | ARGON MEDICAL DEVICES, INC. |
40 | 00886333001170 | 660007040 | 660007040 | Hysterosalpingography (HSG) Catheter 7Fr x 40cm | Hysterosalpingography (HSG) Catheter | ARGON MEDICAL DEVICES, INC. |
41 | 00886333001163 | 660005040 | 660005040 | Hysterosalpingography (HSG) Catheter 5.5Fr x 40cm | Hysterosalpingography (HSG) Catheter | ARGON MEDICAL DEVICES, INC. |
42 | 00859500005035 | CBC-100 | 02827 | FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray) | FemCath | FEMASYS INC. |
43 | 00859500005004 | FSA-200 | FSA-200 | FemVue® Saline-Air Device | FEMASYS INC. | |
44 | 00856589007073 | HPL1-BL1-V2 | One set contains:1 - Branched line with two male luer-lock fittings on the dista One set contains:1 - Branched line with two male luer-lock fittings on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches.1 - Straight gas line, whit one male luer-lock fitting on the distal end and one luer-lock female fitting with a luer activated valve on the proximal end. Length: 96 inches. | Kronner Side-Kick High Pressure Gas Line Set | KRONNER PROTOTYPES, INCORPORATED | |
45 | 00852073002999 | HSG Tray | TMI1199 | Includes 7F Shapeable HS Catheter | NA | C R I |
46 | 00852073002982 | HSG Tray | TMI1198 | Includes 5F Shapeable HS Catheter | NA | C R I |
47 | 00852073002890 | Steen HS Catheter, 7F | TMI1189 | Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media | NA | C R I |
48 | 00852073002883 | Steen HS Catheter, 5F | TMI1188 | Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media | NA | C R I |
49 | 00852073002876 | 7F Shapeable HS Catheter | TMI1187 | Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media | NA | C R I |
50 | 00852073002852 | 5F Shapeable HS Catheter | TMI1185 | Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media | NA | C R I |