gSource - gSilicone Screwdriver 9 1/2" hex 3.5mm w/notch, - GSOURCE LLC

Duns Number:008162518

Device Description: gSilicone Screwdriver 9 1/2" hex 3.5mm w/notch, silicone hdl, green

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

gS 86.4635

Brand Name

gSource

Version/Model Number

gS 86.4635

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

cc1527cc-cb48-4ca2-976c-fc132939b53b

Public Version Date

August 18, 2022

Public Version Number

2

DI Record Publish Date

March 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GSOURCE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4617
2 A medical device with a moderate to high risk that requires special controls. 280