Catalog Number

STR4922-8-500

Brand Name

NA

Version/Model Number

STR4922-8-500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 08, 2016

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

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

K081586

Product Code

KTT

Product Code Name

APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Public Device Record Key

4792d411-1752-441b-bc34-0a98aa9c3ef9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-