Catalog Number

71101000

Brand Name

Cannulated Screws

Version/Model Number

71101000

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

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

K060736,K060736

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

3504009e-781e-4be3-92bf-66acd1e95428

Public Version Date

November 03, 2020

Public Version Number

4

DI Record Publish Date

August 29, 2015

Package DI Number

23596010459521

Quantity per Package

6

Contains DI Package

03596010459527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX