Catalog Number

gS 27.7712

Brand Name

gSource

Version/Model Number

gS 27.7712

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HNB

Product Code Name

Spoon, Ophthalmic

Public Device Record Key

6e205d6d-6219-404f-bcea-156dcd74f22a

Public Version Date

September 21, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-