AccessGUDID - DEVICE: Humelock II Cemented Reversible Shoulder (03701037308448)

GUDID

Device Identifier (DI) Information

Brand Name: Humelock II Cemented Reversible Shoulder
Version or Model: 901-0609
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901-0609
Company Name: FX SOLUTIONS

Primary DI Number: 03701037308448
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 263076196 *Terms of Use

Device Description: MOBILITY TRIAL CUP Ø32 + 9

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):	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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 88082a10-8950-4152-b6a1-a7de8e02f304
Public Version Date: October 07, 2021
Public Version Number: 2
DI Record Publish Date: April 18, 2019