AccessGUDID - DEVICE: Columbus® REVISION (04046963341329)

GUDID

Brand Name: Columbus® REVISION
Version or Model: NR467K
Catalog Number: NR467K
Company Name: Aesculap AG

Primary DI Number: 04046963341329
Issuing Agency: GS1
Device Count: 1

Device Description: COLUMBUS REV FEMUR SPACER DISTAL F7 5MM

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Knee arthroplasty wedge	A sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

Product Code	Product Code Name
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
Device Size Text, specify: Height : 5.000 MM
Device Size Text, specify: Figure / Size : F7
Device Size Text, specify: Implant Fixation : cemented

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2015
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(888)229-3002
Email: setworld_orders@aesculap.com