AccessGUDID - DEVICE: Anatomical Shoulder™ Bigliani/Flatow® (00889024481244)

GUDID

Device Identifier (DI) Information

Brand Name: Anatomical Shoulder™ Bigliani/Flatow®
Version or Model: 01.04250.048
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01.04250.048
Company Name: Zimmer GmbH

Primary DI Number: 00889024481244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488133448 *Terms of Use

Device Description: AS™ B/F® ADAPTOR 48°

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
60512	Shoulder humeral body prosthesis	A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.	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

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
Device Size Text, specify: 48°

Device Record Status

Public Device Record Key: 0fe3ef14-fe23-42bf-a111-32cd861e0d9f
Public Version Date: June 28, 2023
Public Version Number: 6
DI Record Publish Date: July 27, 2017