gSource - Keyes Punch 4" 3mm - GSOURCE LLC

Duns Number:008162518

Device Description: Keyes Punch 4" 3mm

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More Product Details

Catalog Number

gS 50.6120

Brand Name

gSource

Version/Model Number

gS 50.6120

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

LRY

Product Code Name

Punch, Surgical

Device Record Status

Public Device Record Key

d18dc217-c7dc-4e0d-a7b9-a8721b1dd729

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 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