AccessGUDID - DEVICE: Tahoe Unicompartmental Knee System (00840286859950)

GUDID

Device Identifier (DI) Information

Brand Name: Tahoe Unicompartmental Knee System
Version or Model: 2801-0-3432
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2801-0-3432
Company Name: Shalby Advanced Technologies, Inc.

Primary DI Number: 00840286859950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085976260 *Terms of Use

Device Description: Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long

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?
66934	Orthopaedic intraoperative positioning pin, reusable	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFC	Driver, Surgical, Pin

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: Fixation Pin, Tri face with Tri Hub, OD 3.2mm, 4" Long

Device Record Status

Public Device Record Key: 0db086b4-be84-4912-863d-385e20cac3a8
Public Version Date: May 30, 2025
Public Version Number: 1
DI Record Publish Date: May 22, 2025