Catalog Number

gS 78.8300

Brand Name

gSource

Version/Model Number

gS 78.8300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K100736

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

77c8a023-647f-4ef1-a717-f9670856c2df

Public Version Date

July 28, 2021

Public Version Number

1

DI Record Publish Date

July 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-