DYNAMIC AXIAL FIXATOR - ALLEN WRENCH, 3 MM - ORTHOFIX SRL

Duns Number:438793622

Device Description: ALLEN WRENCH, 3 MM

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More Product Details

Catalog Number

10012

Brand Name

DYNAMIC AXIAL FIXATOR

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K955848

Product Code Details

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Device Record Status

Public Device Record Key

3634fcf0-7def-47e0-9a11-faf7286d0d26

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOFIX SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 6371