MatrixNEURO - TI MATRIXNEURO EMERGENCY SCREW 3MM - Synthes GmbH

Duns Number:486711679

Device Description: TI MATRIXNEURO EMERGENCY SCREW 3MM

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


More Product Details

Catalog Number

0450311305

Brand Name

MatrixNEURO

Version/Model Number

04.503.113.05

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

K042365,K123723,K042365,K123723

Product Code Details

Product Code

GWO

Product Code Name

Plate, cranioplasty, preformed, alterable

Device Record Status

Public Device Record Key

0552ae81-8243-4492-988e-13a3542bf6a7

Public Version Date

April 25, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8630
2 A medical device with a moderate to high risk that requires special controls. 16671
U Unclassified 2