QuadVantage

FDA UDI

Class I (US FDA UDI)

by Quadvantage Technology, Inc.

Identity

Trade Name: QuadVantage FDA UDI
Generic Name: Tendon stripper FDA UDI
Device Name: QuadVantage COBRA Harvester - Re-usable instrument used to harvest/ shape the full length of the quadriceps graft prior to separating it from the quadriceps tendon. Uses disposable blades supplied separately. FDA UDI
Model / Reference: 31001 FDA UDI
Description: QuadVantage COBRA Harvester - Re-usable instrument used to harvest/ shape the full length of the quadriceps graft prior to separating it from the quadriceps tendon. Uses disposable blades supplied separately. FDA UDI

Identifiers

Catalog Number: 31001 FDA UDI
Primary DI / UDI-DI: 00850050146063 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Tendon stripper FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Tendon stripper

QuadVantage by Quadvantage Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Quadvantage Technology, Inc.

Sources (1)

FDA UDI 4e42b8d5-e8da-48f1-90fe-556bcd68cea6 35 fields · synced May 30, 2026