FDA UDI
In Commercial Distribution
🇺🇸 United States
Valtchev Uterine Mobilizer
DI: 00627843701828
·
Model: 18
·
Conkin Surgical Instruments Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Valtchev Uterine Mobilizer
- Primary DI
- 00627843701828
- Version / Model
- 18
- Catalog Number
- 18
- 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
- d5e2f017-0d6b-433f-9136-9620119ba665
Device Description
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.
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 |
|---|---|---|---|---|---|---|
| Primary | 00627843701828 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 55 | Millimeter |