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QuadVantage

FDA UDI

Class I (US FDA UDI)

by Quadvantage Technology, Inc.

Identity

Trade Name
QuadVantage FDA UDI
Generic Name
Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
QuadVantage Tendon Only Autograft Instrument Kit. Full set of re-usable instruments for performing a quadriceps autograft without a bone plug. Packaged in an 11” x 7” x 1.25” sterilization tray. Three Instruments included are the VariBlade UDI00850050146049, the QuadSabre UDI00850050146056 and the Cobra Harvester UDI00850050146063. Instruments are re-usable and must be sterilized per instructions provided by the referenced IFU found at quadvantage.com/IFU prior to use. FDA UDI
Model / Reference
41008 FDA UDI
Description
QuadVantage Tendon Only Autograft Instrument Kit. Full set of re-usable instruments for performing a quadriceps autograft without a bone plug. Packaged in an 11” x 7” x 1.25” sterilization tray. Three Instruments included are the VariBlade UDI00850050146049, the QuadSabre UDI00850050146056 and the Cobra Harvester UDI00850050146063. Instruments are re-usable and must be sterilized per instructions provided by the referenced IFU found at quadvantage.com/IFU prior to use. FDA UDI

Identifiers

Catalog Number
41008 FDA UDI
Primary DI / UDI-DI
00850050146018 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Arthroscopic surgical procedure kit, non-medicated, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Arthroscopic surgical procedure kit, non-medicated, reusable

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

Similar devices

Also classified as Arthroscopic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Quadvantage Technology, Inc.

Sources (1)

  • FDA UDI d67b90d7-8d4c-407d-9e0b-48a4aba767c4 35 fields · synced Jun 1, 2026