| 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 | 00627843701873 | 8 | 8 | This is the large locking screw for the VUM-6 and is part of the VUM-6 when sold This is the large locking screw for the VUM-6 and is part of the VUM-6 when sold as a complete unit. The locking screw has no stand alone functionality and is to be used in conjunction with the VUM-6 uterine mobilizer. This is a replacement part that can be ordered separately. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 2 | 00627843701866 | 9A | 9A | This item is the VUM-6 Tube for Dye Injection which is an integral part of the V This item is the VUM-6 Tube for Dye Injection which is an integral part of the Valtchev Uterine Mobilizer, Model VUM-6. The tube has no stand alone functionality and is part of the VUM-6 device. This is a replacement part that can be ordered separately if needed. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 3 | 00627843701859 | VT | VT | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel tenaculum. The Valtchev Tenaculum is used to hold the VUM-6 uterine mobilizer in place when the cannulas 15A or 16A are used for injection of either dye or an X-ray contrast medium. This tenaculum has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 4 | 00627843701842 | 20 | 20 | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel obturator No. 20, having a length of 100 mm and shaft thickness of 10 mm. The pin on the obturator must slip into the notch of the head of the VUM-6 base instrument. The obturator has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 5 | 00627843701835 | 19 | 19 | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel obturator No. 19, having a length of 80 mm and shaft thickness of 8 mm. The pin on the obturator must slip into the notch of the head of the VUM-6 base instrument. The obturator has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 6 | 00627843701828 | 18 | 18 | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel obturator No. 18, having a length of 55 mm and shaft thickness of 3 mm. The pin on the obturator must slip into the notch of the head of the VUM-6 base instrument. The obturator has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 7 | 00627843701811 | 17 | 17 | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel obturator having a length of 45 mm and shaft thickness of 3 mm. The pin on the obturator must slip into the notch of the head of the VUM-6 base instrument. The obturator has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 8 | 00627843701804 | 16A | 16A | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel cannula having a length of 83 mm and shaft thickness of 3 mm. The pin on the cannula must slip into the notch of the head of the VUM-6 base instrument. The cannula has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 9 | 00627843701798 | 15A | 15A | This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless ste This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel cannula having a length of 72 mm and shaft thickness of 3 mm. The pin on the cannula must slip into the notch of the head of the VUM-6 base instrument. The cannula has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 10 | 00627843701781 | VUM-6 | VUM-6 | THE VALTCHEV® UTERINE MOBILIZER, MODEL VUM-6 consists of a body and interchangea THE VALTCHEV® UTERINE MOBILIZER, MODEL VUM-6 consists of a body and interchangeable obturators and cannulas. The body consists of a metal bar and a metal tube which pivot the head. One end of the tube is attached to a piston and the opposite end is attached to a Luer syringe connector. The locking wheel is also attached to the tube. The locking wheel is held in place by a lock. The arm space bar permits manipulation of the head. By means of alocking screw on the upper end of the arm space bar the Mobilizer can be locked in the desired position. The finger ring is located at the lower end of the arm spacer bar. The head accommodates, in its cavity, an obturator or a cannula locking in place by a lock. The four uterine obturators, which are of different lengths and thicknesses are used as follows: No.17 and No.18 are for mobilization of a smaller uterus, No.19 and No.20 are for mobilization of larger uterus. The cannulas: (15A) and (16A) are used for injection of either dye or an X-ray contrast medium. The syringe for injection is attached to the Luer syringe connector. The Mobilizer is held in place by a Valtchev® tenaculum, supported by a tenaculum holder and held taut by a spring. This device is reusable. The attachments have no stand alone functionality, however can be ordered separately. | Valtchev Uterine Mobilizer | CONKIN SURGICAL INSTRUMENTS LTD |
| 11 | B296M03560 | M0356 | single unit | CUSTOM ASSEMBLIES HSG | TITUS MEDICAL LLC | |
| 12 | B296E07070 | E0707 | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 13 | B296E0700FR03 | E0700-FR | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 14 | B296E0700FIRM00 | E0700-FIRM | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 15 | B296E062050 | E06-205 | single unit | Ultra Catheter | TITUS MEDICAL LLC | |
| 16 | B296E050507 | E0505 | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 17 | B296E0500FR01 | E0500-FR | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 18 | B296E0500FIRM0 | E0500-FIRM | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 19 | B296C070709 | C0707 | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 20 | B296C0700FR01 | C0700-FR | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 21 | B296C0700FIRM0 | C0700-FIRM | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 22 | B296C0620508 | C06-205 | Case of 25 Units | Ultra Catheter | TITUS MEDICAL LLC | |
| 23 | B296C050505 | C0505 | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 24 | B296C0500FR0 | C0500-FR | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 25 | B296C0500FIRM0 | C0500-FIRM | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 26 | B296B070708 | B0707 | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 27 | B296B0700FR00 | B0700-FR | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 28 | B296B0700FIRM0 | B0700-FIRM | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 29 | B296B05050 | B0505 | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 30 | B296B0500FR0 | B0500-FR | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 31 | B296B0500FIRM0 | B0500-FIRM | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 32 | B296615007103 | 61-50071 | single unit | H/S Catheter | TITUS MEDICAL LLC | |
| 33 | B29661500702 | 61-5007 | box of 10 units | H/S Catheter | TITUS MEDICAL LLC | |
| 34 | B296615005101 | 61-50051 | single unit | H/S Catheter | TITUS MEDICAL LLC | |
| 35 | B29661500500 | 61-5005 | box of 10 units | H/S Catheter | TITUS MEDICAL LLC | |
| 36 | B296063071 | 06-307 | 1 HSG/SIS Tray with 7fr Catheter | HSG/SIS Tray with 7fr Catheter | TITUS MEDICAL LLC | |
| 37 | B296063070 | 06-307 | Box of 10 HSG/SIS Trays/Kits | HSG Trays | TITUS MEDICAL LLC | |
| 38 | B296063051 | 06-305 | 1 HSG/SIS Tray/Kit with 5fr HSG Catheter | HSG/SIS Tray/Kit with 5fr HSG Catheter | TITUS MEDICAL LLC | |
| 39 | B296063050 | 06-305 | Box of 10 HSG/SIS Trays/Kits | HSG Trays | TITUS MEDICAL LLC | |
| 40 | B296063001 | 06-300 | 1 HSG/SIS Tray No Catheter included | 1 HSG/SIS Tray No Catheter | TITUS MEDICAL LLC | |
| 41 | B296063000 | 06-300 | 06-300 | Box of 10 HSG/SIS Procedure Trays with No Catheter Included | 10 HSG/SIS Procedure Trays | TITUS MEDICAL LLC |
| 42 | B296062050 | 06-205 | box of 10 units | Ultra Catheter | TITUS MEDICAL LLC | |
| 43 | B29606107X400 | 06-107X40 | Case of 40 Units | Sonocath | TITUS MEDICAL LLC | |
| 44 | B29606107X10 | 06-107X1 | single unit | Sonocath | TITUS MEDICAL LLC | |
| 45 | B29606107X0 | 06-107X | box of 10 units | Sonocath | TITUS MEDICAL LLC | |
| 46 | B29606107F400 | 06-107F40 | Case of 40 Units | HSG Catheter | TITUS MEDICAL LLC | |
| 47 | B29606107F10 | 06-107F1 | single unit | HSG Catheter | TITUS MEDICAL LLC | |
| 48 | B29606107F0 | 06-107F | box of 10 units | HSG Catheter | TITUS MEDICAL LLC | |
| 49 | B296061070 | 06-107 | Case of 100 Units Bulk | HSG Catheter | TITUS MEDICAL LLC | |
| 50 | B29606105X400 | 06-105X40 | Case of 40 Units | Sonocath | TITUS MEDICAL LLC |