AccessGUDID - DEVICE: Humelock II Cemented Reversible Shoulder (03701037301517)

GUDID

Device Identifier (DI) Information

Brand Name: Humelock II Cemented Reversible Shoulder
Version or Model: 314-0706
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 314-0706
Company Name: FX SOLUTIONS

Primary DI Number: 03701037301517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 263076196 *Terms of Use

Device Description: HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +6

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?
48092	Polyethylene reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150488	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: 6 Millimeter

Device Record Status

Public Device Record Key: fa820438-6735-449c-a84f-f003e248be88
Public Version Date: October 07, 2021
Public Version Number: 4
DI Record Publish Date: June 09, 2016