AccessGUDID - DEVICE: Comprehensive® Reverse Shoulder (00887868519291)

GUDID

Device Identifier (DI) Information

Brand Name: Comprehensive® Reverse Shoulder
Version or Model: 406202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 406202
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868519291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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?
36259	Shoulder glenoid fossa prosthesis, prefabricated	An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	shoulder prosthesis, reverse configuration
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080642	000
K193373	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 28 mm / 10°

Device Record Status

Public Device Record Key: 9c7a9c0f-ea05-4df6-8b4e-dbd0a4000b73
Public Version Date: May 30, 2025
Public Version Number: 2
DI Record Publish Date: April 23, 2022