Catalog Number

JTSDF-L-SM

Brand Name

Stanmore

Version/Model Number

JTSDF-L-SM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092138,K133152

Product Code

KRO

Product Code Name

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Public Device Record Key

ab0ccad2-a174-4eed-a14f-e8afd7c85c4f

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

July 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-