Cannulated Compression Headless Screw - 2.0MM/1.1MM DOUBLE DRILL GUIDE - Tyber Medical LLC

Duns Number:010968002

Device Description: 2.0MM/1.1MM DOUBLE DRILL GUIDE

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More Product Details

Catalog Number

03.333.401

Brand Name

Cannulated Compression Headless Screw

Version/Model Number

03.333.401

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

-

Product Code Details

Product Code

FZX

Product Code Name

Guide, surgical, instrument

Device Record Status

Public Device Record Key

1c73063e-a994-4151-bbcd-dfb282751716

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

June 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYBER MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 440
2 A medical device with a moderate to high risk that requires special controls. 7793