FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Biover
DI: 07640174510207
·
Model: TKMV-1
·
Biover AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Biover
- Primary DI
- 07640174510207
- Version / Model
- TKMV-1
- Catalog Number
- TKMV-1
- Company Name
- Biover AG
- Labeler DUNS
- 482102712
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 5
- Public Version Date
- 2026-02-27
- Public Version Status
- Update
- Public Device Record Key
- 6acbe9ba-6c41-4868-be59-3692efebeb98
- Distribution End Date
- 2023-10-30
Device Description
Disposable Microvascular Clamps, Veins, single, Ø 1 to 2 mm
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 |
|---|---|---|---|---|---|---|
| Primary | 07640174510207 | GS1 | ||||
| Package | 07640174510214 | GS1 | Box | 10 | Not in Commercial Distribution | 2022-01-25 |
Customer Contacts
- Phone
- +41416300022
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Clipping power: 30 GRM | ||
| Length | 17.0 | Millimeter | |
| Width | 3 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius