AccessGUDID - DEVICE: MODIFIED MINI TRAY +10 3MM OFFSET (00889024585355)

GUDID

Device Identifier (DI) Information

Brand Name: MODIFIED MINI TRAY +10 3MM OFFSET
Version or Model: SSI005789
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SSI005789
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00889024585355
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?
60937	Reverse shoulder cup prosthesis trial, reusable	A copy of a final reverse shoulder prosthesis cup designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is intended to connect to a reverse shoulder prosthesis/trial prosthesis body and articulates with a reverse shoulder prosthesis/trial prosthesis head; it is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181611	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
Device Size Text, specify: +10 3mm

Device Record Status

Public Device Record Key: 0960e832-6e2d-45fd-8f31-177680ef655a
Public Version Date: May 30, 2025
Public Version Number: 3
DI Record Publish Date: January 13, 2020