Dynamic Axial Fixator - DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK - ORTHOFIX SRL

Duns Number:438793622

Device Description: DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK CONNECT

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More Product Details

Catalog Number

1-1100401

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

a9a13194-f1d5-4666-80d2-6f373cf8aa6b

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

September 16, 2016

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