Identity
- Trade Name
- Valtchev Uterine Mobilizer FDA UDI
- Generic Name
- Uterine elevator FDA UDI
- Device Name
- 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 a locking 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. FDA UDI
- Model / Reference
- VUM-6 FDA UDI
- Description
- 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 a locking 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. FDA UDI
Identifiers
- Catalog Number
- VUM-6 FDA UDI
- Primary DI / UDI-DI
- 00627843701781 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Uterine elevator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Uterine elevator
Valtchev Uterine Mobilizer by Conkin Surgical Instruments , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conkin Surgical Instruments , Ltd.
Sources (1)
- FDA UDI 5ed245cf-c7aa-46af-9b52-bb3f58eef384 34 fields · synced May 30, 2026