AccessGUDID - DEVICE: GLOBAL (10603295007265)

GUDID

Device Identifier (DI) Information

Brand Name: GLOBAL
Version or Model: 1137-86-025
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 113786025
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295007265
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: GLOBAL ENDURON PE SHOULDER - GLENOID PEG SIZE 48

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?
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
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905786	000
K914000	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: 97c45c8e-c22d-4708-b3e3-25c8f83c8898
Public Version Date: July 19, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2015