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 | 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 | ||
14 | 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 | |
15 | 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 | |
16 | 00814247020284 | KDT-1000 | Koala Toco® Single-Use Tocodyamometer | HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | Koala Toco® | |
17 | 00814247020017 | UM700 | ClearView Uterine Manipulator, 7cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
18 | 00814247020666 | VAC-6000S | Kiwi® Vacuum Delivery System ProCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® ProCup® | |
19 | 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 | ||
20 | 00814247020802 | PRS-EVAL | Traxi Panniculus Retractor with Retentus Technology | CCX | Support, Patient Position | traxi® Panniculus Retractor | ||
21 | 00814247020345 | PRS-1030 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor | |
22 | 00814247020659 | VAC-6000MTE | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
23 | 00814247020642 | VAC-6000MT | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
24 | 00814247020635 | VAC-6000ME | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
25 | 00814247020628 | VAC-6000C | Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® Omni-C Cup® | |
26 | 00814247020611 | UM950 | ClearView Total Uterine Manipulator, 9cm tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Total Uterine Manipulator | |
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 | 20612479161546 | 11-19611 | GYNECATH H/S CATHETER 7FR (10/ | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | |
2 | 20612479161539 | 11-19610 | GYNECATH H/S CATHETER 5FR (10/ | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | |
3 | 10850011427153 | 06-307 | Case of 10 HSG/SIS Trays/Kits with 7Fr catheter | HSG Trays/Kits 7fr | TITUS MEDICAL LLC | |
4 | 10850011427146 | 06-305 | Case of 10 HSG/SIS Trays/Kits with 5Fr catheter | HSG/SIS Trays/Kits with 5Fr catheter | TITUS MEDICAL LLC | |
5 | 10842962105273 | HBI-BA071F | HBI-BA071F | HSG CATHETER SET W/BALLOON, 7 Fr, SUREFLEX, STERILE, BOX OF 10 | HNM Women Care | HNM STAINLESS, LLC. |
6 | 10842962105266 | HBI-BA051F | HBI-BA051F | HSG CATHETER SET W/BALLOON, 5 Fr, SUREFLEX, STERILE, BOX OF 10 | HNM Women Care | HNM STAINLESS, LLC. |
7 | 10842962105242 | HBI-UIC5FA | HBI-UIC5FA | BELLOTA SONOHYSTEROGRAPHY CATHETER W/CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, ST BELLOTA SONOHYSTEROGRAPHY CATHETER W/CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, STERILE, BOX OF 25 | HNM Women Care | HNM STAINLESS, LLC. |
8 | 10653405003816 | 60-6085-203A | 60-6085-203A | VCARE EXTRA LARGE, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR | VCARE | CONMED CORPORATION |
9 | 10653405003809 | 60-6085-202A | 60-6085-202A | VCARE LARGE, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR | VCARE | CONMED CORPORATION |
10 | 10653405003793 | 60-6085-201A | 60-6085-201A | VCARE MEDIUM, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR | VCARE | CONMED CORPORATION |
11 | 10653405003748 | 60-6085-200A | 60-6085-200A | VCARE SMALL, UTERINE MANIPULATOR, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR-ELEVATOR | VCARE | CONMED CORPORATION |
12 | 10653405003717 | 60-6080-000A | 60-6080-000A | VCARE DX UTERINE MANIPULATOR/INJECTOR CANNULA | VCARE DX | CONMED CORPORATION |
13 | 09349967004890 | OB-01 | Occluder Balloon | THE O R COMPANY PTY LTD | ||
14 | 09349967003381 | UE-OBPRO-40 | Uterine ElevatOR Pro with OccludOR Balloon | THE O R COMPANY PTY LTD | ||
15 | 09349967003350 | UE-OBPRO-37 | Uterine ElevatOR Pro with OccludOR Balloon | THE O R COMPANY PTY LTD | ||
16 | 09349967003329 | UE-OBPRO-35 | Uterine ElevatOR Pro with OccludOR Balloon | THE O R COMPANY PTY LTD | ||
17 | 09349967003299 | UE-OBPRO-32 | Uterine ElevatOR Pro with OccludOR Balloon | THE O R COMPANY PTY LTD | ||
18 | 09349967003114 | UM-TV | ManipulatOR | THE O R COMPANY PTY LTD | ||
19 | 09349967003084 | UE-POR | Uterine PositionOR | THE O R COMPANY PTY LTD | ||
20 | 09349967003053 | UE-TVPRO-40 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
21 | 09349967003022 | UE-TVPRO-37 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
22 | 09349967002995 | UE-TVPRO-35 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
23 | 09349967002964 | UE-TVPRO-32 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
24 | 09349967002841 | UE-TVPRO-40 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
25 | 09349967002810 | UE-TVPRO-37 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
26 | 09349967002780 | UE-TVPRO-35 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
27 | 09349967002759 | UE-TVPRO-32 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
28 | 09349967002339 | UE-TVPRO-40 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
29 | 09349967002308 | UE-TVPRO-37 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
30 | 09349967002278 | UE-TVPRO-35 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
31 | 09349967002247 | UE-TVPRO-32 | Uterine ElevatOR Pro | THE O R COMPANY PTY LTD | ||
32 | 09349967001028 | DUMI-350A | Diagnostic Uterine Manipulator Injector | DUMI ManipulatOR | THE O R COMPANY PTY LTD | |
33 | 09349967000991 | UE-LHPRO-40 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | ||
34 | 09349967000960 | UE-LHPRO-37 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | ||
35 | 09349967000939 | UE-LHPRO-35 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | ||
36 | 09349967000908 | UE-LHPRO-32 | Uterine ElevatOR PRO with Long Handle | THE O R COMPANY PTY LTD | ||
37 | 09349967000816 | UE-PLH | Uterine PositionOR Pro | THE O R COMPANY PTY LTD | ||
38 | 09349967000335 | 45mm | CTS45-TV | 45mm diameter trans-vaginal tube and uterine manipulator | ColpotomizOR Tube System | SURGI SUPPLIES INTERNATIONAL PTY. LTD. |
39 | 09349967000007 | UM-TV | UM-TV | Uterine Manipulator | ManipulatOR | SURGI SUPPLIES INTERNATIONAL PTY. LTD. |
40 | H671MIS50ST0 | Integrated Stylet | MIS-50ST | Saline/Contrast Media Infusion Catheter, 5 Fr. with Integrated Stylet | TVUS/HSG-Cath | UTAH MEDICAL PRODUCTS, INC. |
41 | H671MIS50P0 | Peel-Away Introducer | MIS-50P | Saline/Contrast Media Infusion Catheter, 5 Fr. with Peel-Away Introducer | TVUS/HSG-Cath | UTAH MEDICAL PRODUCTS, INC. |
42 | H671MIS1000 | Uterine Manipulator | MIS-100 | Laparoscopic Uterine Manipulator-INjector | LUMIN | UTAH MEDICAL PRODUCTS, INC. |
43 | 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 |
44 | 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 | |
45 | 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 | |
46 | 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 | |
47 | 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 | |
48 | 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 | |
49 | 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 | |
50 | 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 |