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Vp1200k™

FDA UDI

Class II (US FDA UDI)

by Vascutek Ltd

Identity

Trade Name
VP1200K™ FDA UDI
Generic Name
Synthetic vascular graft FDA UDI
Device Name
VP1200KAX-BIFEM RIGHT FDA UDI
Model / Reference
251010 FDA UDI
Description
VP1200KAX-BIFEM RIGHT FDA UDI

Identifiers

Catalog Number
251010 FDA UDI
Primary DI / UDI-DI
05037881020051 FDA UDI
510(k) Number
K034010 FDA UDI
FDA Product Code
DSY FDA UDI
GMDN Term
Synthetic vascular graft FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3450 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 10 Millimeter FDA UDI
Length — 100 Centimeter FDA UDI

Vp1200k™ by Vascutek Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K034010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vascutek Ltd

Sources (1)

  • FDA UDI 8b28f7d7-82e6-441a-b242-d0c28e9c727f 39 fields · synced May 30, 2026