NA - TRIBOS 501 Kunststoffzaehne VR66-OK-C4 - Gebdi Dental-Products GmbH

Duns Number:342656675

Device Description: TRIBOS 501 Kunststoffzaehne VR66-OK-C4

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

29501

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)

-

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

ELM

Product Code Name

Denture, plastic, teeth

Device Record Status

Public Device Record Key

2a61315c-5d88-4514-9005-7baf30e929b4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEBDI DENTAL-PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 725