Catalog Number

GS900.053.010

Brand Name

PIN DRIVER

Version/Model Number

GS900.053.010.TW

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

GFC

Product Code Name

Driver, Surgical, Pin

Public Device Record Key

049e9994-cb00-4065-b68c-7f4a20be06d7

Public Version Date

July 13, 2022

Public Version Number

2

DI Record Publish Date

December 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-