gSource - Joseph Rasp 6 1/4" 8mm str fine cross serr - GSOURCE LLC

Duns Number:008162518

Device Description: Joseph Rasp 6 1/4" 8mm str fine cross serr

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More Product Details

Catalog Number

gS 62.1710

Brand Name

gSource

Version/Model Number

gS 62.1710

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

HTR

Product Code Name

Rasp

Device Record Status

Public Device Record Key

fa600a6a-c59b-409d-aa6a-f95d6713e39f

Public Version Date

August 18, 2022

Public Version Number

2

DI Record Publish Date

March 12, 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