Ocata Anterior Cervical System - Screw, Self Tapping, Fixed, 4.0 x 20mm - Kalitec Direct LLC

Duns Number:041956211

Device Description: Screw, Self Tapping, Fixed, 4.0 x 20mm

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More Product Details

Catalog Number

08-STF-4020

Brand Name

Ocata Anterior Cervical System

Version/Model Number

08-STF-4020

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

Yes

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

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

4df90675-d545-4629-8d0b-dcfe3e76b0e4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 29, 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