Neoss Implant System - Neoss TiBase, NP (FX 3.4 S) - Neoss AB

Duns Number:509583543

Device Description: Neoss TiBase, NP (FX 3.4 S)

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More Product Details

Catalog Number

31345

Brand Name

Neoss Implant System

Version/Model Number

31345

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

5873a0db-6bdd-42e0-807e-8e84c4da1db4

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

September 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOSS AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 116
2 A medical device with a moderate to high risk that requires special controls. 276