Flow-Nail™ - FN 58mm CORT Screw - Flow-FX

Duns Number:079293587

Device Description: FN 58mm CORT Screw

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More Product Details

Catalog Number

C58

Brand Name

Flow-Nail™

Version/Model Number

C58

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

K140601

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

3a6e67e7-0529-4c0f-aaac-aaa70e7a57a7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 05, 2017

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