AccessGUDID - DEVICE: AETOS Shoulder System (00885556814390)

GUDID

Device Identifier (DI) Information

Brand Name: AETOS Shoulder System
Version or Model: GBP-0990-502-15F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GBP-0990-502-15F
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556814390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: 15 DEG AUGMENT BASEPLATE FULL WEDGE

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?
48091	Reverse shoulder prosthesis base plate	A sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
PHX	shoulder prosthesis, reverse configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230572	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: fb058af2-06f1-4f99-807a-391eaa30086f
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: June 21, 2023