gSource - Parallel Pliers 7 1/4" with 10mm jaw - GSOURCE LLC

Duns Number:008162518

Device Description: Parallel Pliers 7 1/4" with 10mm jaw

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More Product Details

Catalog Number

gS 81.7040

Brand Name

gSource

Version/Model Number

gS 81.7040

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

JEX

Product Code Name

Plier, Orthodontic

Device Record Status

Public Device Record Key

a6d2b8fd-f6bf-4de8-9d75-7c44f800f215

Public Version Date

October 03, 2022

Public Version Number

2

DI Record Publish Date

February 26, 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