AccessGUDID - DEVICE: Stanmore (05060296232849)

GUDID

Device Identifier (DI) Information

Brand Name: Stanmore
Version or Model: SMLTBC00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SMLTBC00
Company Name: Stanmore Implants Worldwide Ltd

Primary DI Number: 05060296232849
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 Rotating Hinge Poly Cased Bearing XSM

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?
33692	Rotating hinged total knee prosthesis	A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without 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 [?]
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: Extra Small

Device Record Status

Public Device Record Key: 03011598-d7b7-4d3f-aff5-e29e8f05d6de
Public Version Date: June 05, 2023
Public Version Number: 2
DI Record Publish Date: July 18, 2019