Catalog Number

202587

Brand Name

TIMX

Version/Model Number

202587

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2018

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

-

Product Code

HTZ

Product Code Name

INSTRUMENT, CUTTING, ORTHOPEDIC

Public Device Record Key

847bc4b6-92c0-4425-9fec-83850298d16b

Public Version Date

July 31, 2018

Public Version Number

4

DI Record Publish Date

December 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-