AccessGUDID - DEVICE: Humelock II Cemented Shoulder System (03701037300732)

GUDID

Device Identifier (DI) Information

Brand Name: Humelock II Cemented Shoulder System
Version or Model: 112-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112-0000
Company Name: FX SOLUTIONS

Primary DI Number: 03701037300732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 263076196 *Terms of Use

Device Description: DOUBLE TAPER TA6V +0 mm 0°

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?
60512	Shoulder humeral body prosthesis	A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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: 19 Millimeter

Device Record Status

Public Device Record Key: 450917a3-75d1-4ddf-a590-493173bf72ae
Public Version Date: October 07, 2021
Public Version Number: 4
DI Record Publish Date: June 09, 2016