gSource - Frazier Dura Separator 6 1/2", angled blade 1/2" - GSOURCE LLC

Duns Number:008162518

Device Description: Frazier Dura Separator 6 1/2", angled blade 1/2" long, tapered

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More Product Details

Catalog Number

gS 42.7180

Brand Name

gSource

Version/Model Number

gS 42.7180

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GEG

Product Code Name

Elevator, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

a47905c3-9aa3-4a5c-a7e8-8487e4431ba4

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 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