AccessGUDID - DEVICE: COMPREHENSIVE SHOULDER SYSTEM (00880304539655)

GUDID

Device Identifier (DI) Information

Brand Name: COMPREHENSIVE SHOULDER SYSTEM
Version or Model: 31-406988
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-406988
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304539655
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?
47831	Orthopaedic implantation sleeve, reusable	A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKC	Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182516	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: 58MM

Device Record Status

Public Device Record Key: aa67ba4b-9533-4120-b400-e79b4ff107fe
Public Version Date: May 30, 2025
Public Version Number: 2
DI Record Publish Date: July 22, 2019