AccessGUDID - DEVICE: NA (B013DRUJIS0450)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: DRUJ-IS045
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DRUJ-IS045
Company Name: APTIS MEDICAL, LLC

Primary DI Number: B013DRUJIS0450
Issuing Agency: HIBCC
Commercial Distribution End Date: August 27, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 780455338 *Terms of Use

Device Description: Distal Radio-Ulnar Joint Stem, Standard, 4.5 mm Diameter. THIS ITEM IS NO LONGER IN DISTRIBUTION.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
33720	Wrist ulna-head prosthesis	A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXE	Prosthesis, Wrist, Hemi-, Ulnar

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 700dda7b-3b1d-4109-8387-087bb6a196d9
Public Version Date: September 06, 2021
Public Version Number: 1
DI Record Publish Date: August 27, 2021