Catalog Number

013342

Brand Name

SURETAC

Version/Model Number

013342

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2021

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

JDR

Product Code Name

Staple, fixation, bone

Public Device Record Key

74c9a10d-2cd8-4607-9fb6-64d2bb225629

Public Version Date

April 27, 2021

Public Version Number

3

DI Record Publish Date

April 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-