AccessGUDID - DEVICE: LINK Embrace Shoulder System (04026575242351)

GUDID

Device Identifier (DI) Information

Brand Name: LINK Embrace Shoulder System
Version or Model: 640-110/15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 640-110/15
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575242351
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Humeral Standard Stems

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?
39702	Coated shoulder humeral stem prosthesis	A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
PHX	shoulder prosthesis, reverse configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200368	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: 297376b3-b08f-47c3-b63a-a6332bb22b42
Public Version Date: April 01, 2021
Public Version Number: 1
DI Record Publish Date: March 24, 2021