gSource - Bariatric Extra Long Kelly Sponge Forceps 12 1/2" - GSOURCE LLC

Duns Number:008162518

Device Description: Bariatric Extra Long Kelly Sponge Forceps 12 1/2" cvd fenestrated serr

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More Product Details

Catalog Number

gS 20.8000

Brand Name

gSource

Version/Model Number

gS 20.8000

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

KAE

Product Code Name

Forceps, Ent

Device Record Status

Public Device Record Key

5f244b93-3909-4d69-b101-b428a72f5c50

Public Version Date

August 10, 2022

Public Version Number

4

DI Record Publish Date

January 09, 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