AccessGUDID - DEVICE: LINK Embrace Shoulder System Line Extension (04026575533657)

GUDID

Device Identifier (DI) Information

Brand Name: LINK Embrace Shoulder System Line Extension
Version or Model: 643-010/01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 643-010/01
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575533657
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Reverse tray, uncemented, CoCrMo, extended

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:	Yes
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?
60511	Reverse shoulder prosthesis body	A sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231445	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 22e49c1a-8a10-4f56-948a-c515512c54ca
Public Version Date: January 30, 2024
Public Version Number: 1
DI Record Publish Date: January 22, 2024