MATIRA ANTERIOR CERVICAL SYSTEM - Driver Shaft, T10 Split Tip - Kalitec Direct LLC

Duns Number:041956211

Device Description: Driver Shaft, T10 Split Tip

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


More Product Details

Catalog Number

07-K01-7002

Brand Name

MATIRA ANTERIOR CERVICAL SYSTEM

Version/Model Number

07-K01-7002

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

-

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

HWD

Product Code Name

Starter, Bone Screw

Device Record Status

Public Device Record Key

fec7d6b5-d02c-4a41-a45d-b84ea02aee42

Public Version Date

January 10, 2020

Public Version Number

5

DI Record Publish Date

October 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KALITEC DIRECT LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1286
2 A medical device with a moderate to high risk that requires special controls. 1900