Catalog Number

0275701400

Brand Name

TPS

Version/Model Number

0275701400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2019

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

K941333

Product Code

HRX

Product Code Name

ARTHROSCOPE

Public Device Record Key

306e30fd-fc4b-4177-b3ef-efecb83c494b

Public Version Date

September 30, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-