Catalog Number

1271-157

Brand Name

WINBERG TENDON KNIFE

Version/Model Number

1271-157

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

-

Product Code

HTS

Product Code Name

KNIFE, ORTHOPEDIC

Public Device Record Key

14ae32a1-e9fd-4d69-b7fd-53ef24f59d4a

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-