AccessGUDID - DEVICE: SOLAR (07613327137811)

GUDID

Device Identifier (DI) Information

Brand Name: SOLAR
Version or Model: 5350-4518
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5350-4518
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327137811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Shoulder Humeral Head

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Total shoulder prosthesis	A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

GMDN Preferred Term Name

GMDN Definition

Total shoulder prosthesis

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

FDA Product Code

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Product Code	Product Code Name
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935593	000
K955731	000
K990598	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter: 45.0 Millimeter
Device Size Text, specify: Thickness: 18.0 Millimeter

Device Record Status

Public Device Record Key: 0c3bf56d-bc9a-44b0-b344-62db71f72931
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015