AccessGUDID - DEVICE: AS univation® XF (04046964053733)

GUDID

Device Identifier (DI) Information

Brand Name: AS univation® XF
Version or Model: NO162Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NO162Z
Company Name: Aesculap AG

Primary DI Number: 04046964053733
Issuing Agency: GS1
Commercial Distribution End Date: November 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: AS UNIVATION XF TIBIA CEMENTED T1 LM

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):	Yes
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?
48068	Uncoated unicondylar knee tibia prosthesis, metallic	A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component and an insert, and its implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRY	PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Implant Fixation : cemented
Device Size Text, specify: Anatomic Term : left medial
Device Size Text, specify: Figure/Size : T1

Device Record Status

Public Device Record Key: 73843f82-70f7-428e-abac-09cb329ec84a
Public Version Date: November 13, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2015