Flow-Nail™ - FN Lag Screw GWG Trocar - Flow-FX

Duns Number:079293587

Device Description: FN Lag Screw GWG Trocar

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More Product Details

Catalog Number

101-22

Brand Name

Flow-Nail™

Version/Model Number

101-22

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140601

Product Code Details

Product Code

DRC

Product Code Name

Trocar

Device Record Status

Public Device Record Key

ad94f9ed-600d-4236-b52b-8dd1a7770384

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLOW-FX" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 85
2 A medical device with a moderate to high risk that requires special controls. 1067