gSource - K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1 - GSOURCE LLC

Duns Number:008162518

Device Description: K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1

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More Product Details

Catalog Number

gS 79.2106

Brand Name

gSource

Version/Model Number

gS 79.2106

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030665

Product Code Details

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

8bb71322-e0e9-48a7-9217-55f09f7924f9

Public Version Date

July 26, 2021

Public Version Number

1

DI Record Publish Date

July 16, 2021

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