AccessGUDID - DEVICE: QuadVantage (00850050146018)

GUDID

Device Identifier (DI) Information

Brand Name: QuadVantage
Version or Model: 41008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41008
Company Name: Quadvantage Technology, Inc.

Primary DI Number: 00850050146018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112134851 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44091	Arthroscopic surgical procedure kit, non-medicated, reusable	A collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d67b90d7-8d4c-407d-9e0b-48a4aba767c4
Public Version Date: June 27, 2023
Public Version Number: 1
DI Record Publish Date: June 19, 2023