AccessGUDID - DEVICE: Humelock II Cemented Shoulder System (03701037300169)

GUDID

Device Identifier (DI) Information

Brand Name: Humelock II Cemented Shoulder System
Version or Model: 105-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105-0001
Company Name: FX SOLUTIONS

Primary DI Number: 03701037300169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 263076196 *Terms of Use

Device Description: 2 PEGS GLENOID PE CEMENTED SIZE XS

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):	No
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 [?]
K123814	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
Special Storage Condition, Specify: Store away from light and sunlight Store away from moisture

Clinically Relevant Size

[?]

Size Type Text
Height: 27 Millimeter

Device Record Status

Public Device Record Key: 62bd2668-5588-4c33-a402-d8c1dbd97fc8
Public Version Date: October 07, 2021
Public Version Number: 5
DI Record Publish Date: June 09, 2016