AccessGUDID - DEVICE: Stanmore (05060296236090)

GUDID

Device Identifier (DI) Information

Brand Name: Stanmore
Version or Model: JTSDF-L-SM
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: JTSDF-L-SM
Company Name: Stanmore Implants Worldwide Ltd

Primary DI Number: 05060296236090
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: JTS Distal Femur Left SM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32831	Uncoated knee femur prosthesis, metallic	An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.	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 [?]
K092138	000
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: Small

Device Record Status

Public Device Record Key: ab0ccad2-a174-4eed-a14f-e8afd7c85c4f
Public Version Date: June 05, 2023
Public Version Number: 3
DI Record Publish Date: July 18, 2019