AccessGUDID - DEVICE: Stanmore (05060296230296)

GUDID

Device Identifier (DI) Information

Brand Name: Stanmore
Version or Model: mktp/Sm15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MKTP-SM15
Company Name: Stanmore Implants Worldwide Ltd

Primary DI Number: 05060296230296
Issuing Agency: GS1
Commercial Distribution End Date: June 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 494989502 *Terms of Use

Device Description: Tibial Plateau Plate SM 15mm

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?
48067	Knee arthroplasty wedge	An implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133152	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness: 15 millimeters
Device Size Text, specify: Small

Device Record Status

Public Device Record Key: efa2892c-dcc8-45d1-b87c-e6f41a68030c
Public Version Date: June 05, 2023
Public Version Number: 3
DI Record Publish Date: July 18, 2019