FDA UDI
In Commercial Distribution
🇺🇸 United States
GEM BIOVER Microvascular Clamp
DI: 00844735006346
·
Model: TKS-2
·
SYNOVIS MICRO COMPANIES ALLIANCE, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GEM BIOVER Microvascular Clamp
- Primary DI
- 00844735006346
- Version / Model
- TKS-2
- Catalog Number
- TKS-2
- Company Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC
- Labeler DUNS
- 031284586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-19
- Public Version
- 3
- Public Version Date
- 2026-03-02
- Public Version Status
- Update
- Public Device Record Key
- b96f80bb-9702-44cf-be0c-9b1201a48622
Device Description
Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXC | CLAMP, VASCULAR | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62480 | Surgical bulldog clamp, single-use | A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10844735006343 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 00844735006346 | GS1 |
Customer Contacts
- Phone
- +1(800)510-3318
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Vessel Diameter: < 1 mm | ||
| Device Size Text, specify | Clamping Force: 40 g |