AccessGUDID - DEVICE: Tahoe Unicompartmental Knee System (00840286847148)

GUDID

Device Identifier (DI) Information

Brand Name: Tahoe Unicompartmental Knee System
Version or Model: 3000-0-0076
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3000-0-0076
Company Name: Shalby Advanced Technologies, Inc.

Primary DI Number: 00840286847148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085976260 *Terms of Use

Device Description: TUKS, Femoral IM Rod Extractor, T-Handle

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:	No
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?
63105	Orthopaedic instrument extractor	A hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWB	Extractor

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
Device Size Text, specify: Femoral IM Rod Extractor, T-Handle

Device Record Status

Public Device Record Key: b531c620-9b64-4e43-8513-31e17de68c8d
Public Version Date: May 30, 2025
Public Version Number: 1
DI Record Publish Date: May 22, 2025