Valtchev Uterine Mobilizer
Basic Information
- Brand Name
- Valtchev Uterine Mobilizer
- Primary DI
- 00627843701781
- Version / Model
- VUM-6
- Catalog Number
- VUM-6
- Company Name
- Conkin Surgical Instruments Ltd
- Labeler DUNS
- 257261032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-02-22
- Public Version Status
- Update
- Public Device Record Key
- 5ed245cf-c7aa-46af-9b52-bb3f58eef384
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15677 | Uterine elevator | A hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10627843701788 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00627843701781 | GS1 |