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InTrack® Inserts

FDA UDI

Class II (US FDA UDI)

by Vitalitec International, Inc.

Identity

Trade Name
InTrack® Inserts FDA UDI
Generic Name
Artery clamp FDA UDI
Device Name
Supplied as a pair for use in jaws of resuable clamps. FDA UDI
Model / Reference
N-10141vNS FDA UDI
Description
Supplied as a pair for use in jaws of resuable clamps. FDA UDI

Identifiers

Catalog Number
N-10141vNS FDA UDI
Primary DI / UDI-DI
00852621004840 FDA UDI
510(k) Number
K992980 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Artery clamp 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Artery clamp

InTrack® Inserts by Vitalitec International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Artery clamp.

Cleared under the same submission

K992980 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vitalitec International, Inc.

Sources (1)

  • FDA UDI b4c7ca88-4605-42d9-9244-dd3b6594c133 36 fields · synced May 31, 2026