Cannulated Compression Headless Screw - 11.0MM/9.0MM TISSUE PROTECTOR - Tyber Medical LLC

Duns Number:010968002

Device Description: 11.0MM/9.0MM TISSUE PROTECTOR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

03.333.702

Brand Name

Cannulated Compression Headless Screw

Version/Model Number

03.333.702

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

HXI

Product Code Name

PASSER, WIRE, ORTHOPEDIC

Device Record Status

Public Device Record Key

d4cebec6-121d-412c-8175-a71c170075d9

Public Version Date

October 20, 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