AccessGUDID - DEVICE: REUNION (07613327355321)

GUDID

Device Identifier (DI) Information

Brand Name: REUNION
Version or Model: 5571-C-3604-A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5571-C-3604-A
Company Name: Stryker GmbH

Primary DI Number: 07613327355321
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: X3 HUMERAL INSERT

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?
48902	Western equine encephalitis (WEE) virus total antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Western equine encephalitis (WEE) virus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 4.0 Millimeter
Device Size Text, specify: Diameter: 36.0 Millimeter

Device Record Status

Public Device Record Key: 248c182b-777c-40fb-8174-7a87ee94a2c1
Public Version Date: April 14, 2025
Public Version Number: 3
DI Record Publish Date: November 15, 2022