Catalog Number

IMTPRHP-STD

Brand Name

Instrument

Version/Model Number

imtprhp/Std

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

K133152

Product Code

KRO

Product Code Name

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

Public Device Record Key

2a98b03e-fd86-4a95-91e4-ca5969fdda8e

Public Version Date

July 26, 2019

Public Version Number

1

DI Record Publish Date

July 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-