DEGAS Anterior Cervical Plate System - Drill, Adjustable, D4.0mm - CTL MEDICAL CORPORATION

Duns Number:080138504

Device Description: Drill, Adjustable, D4.0mm

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


More Product Details

Catalog Number

-

Brand Name

DEGAS Anterior Cervical Plate System

Version/Model Number

010.7042

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

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

4c445157-9950-4087-8368-48b332949f6a

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

February 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CTL MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 541
2 A medical device with a moderate to high risk that requires special controls. 1990