gSource - Reduction Fcps 266 mm with ball tips - GSOURCE LLC

Duns Number:008162518

Device Description: Reduction Fcps 266 mm with ball tips

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More Product Details

Catalog Number

gS 46.5040

Brand Name

gSource

Version/Model Number

gS 46.5040

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

GEN

Product Code Name

Forceps, General & Plastic Surgery

Device Record Status

Public Device Record Key

3d87e1ee-cdd2-4c46-9211-525365ee65d5

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

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