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Biover

FDA UDI

Class II (US FDA UDI)

by Biover AG

Identity

Trade Name
Biover FDA UDI
Generic Name
Vascular clamp, single-use FDA UDI
Device Name
Disposable Microvascular Clamps, Veins, single, Ø 1 to 2 mm FDA UDI
Model / Reference
TKMV-1 FDA UDI
Description
Disposable Microvascular Clamps, Veins, single, Ø 1 to 2 mm FDA UDI

Identifiers

Catalog Number
TKMV-1 FDA UDI
Primary DI / UDI-DI
07640174510207 FDA UDI
510(k) Number
K011208 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Vascular clamp, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 3.0 Centimeter FDA UDI
Length — 17.0 Millimeter FDA UDI

Category: Vascular clamp, single-use

Biover by Biover AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular clamp, single-use.

Cleared under the same submission

K011208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biover AG

Sources (1)

  • FDA UDI 6acbe9ba-6c41-4868-be59-3692efebeb98 38 fields · synced Jun 8, 2026