AccessGUDID - DEVICE: UniSyn Hip System (00840286844895)

GUDID

Device Identifier (DI) Information

Brand Name: UniSyn Hip System
Version or Model: 4462-42626-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4462-42626-B
Company Name: Shalby Advanced Technologies, Inc.

Primary DI Number: 00840286844895
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085976260 *Terms of Use

Device Description: Broach, Standard, Tapered Connector, Unisyn, Size 26/26

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?
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTQ	Broach

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: Broach, Standard, Tapered Connector, Unisyn, Size 26/26

Device Record Status

Public Device Record Key: 0aa146e9-3858-43c6-a80e-9c24d5f7b000
Public Version Date: May 22, 2025
Public Version Number: 1
DI Record Publish Date: May 14, 2025