Freeprint denture pink 385 1.000 g neutral - DETAX GmbH & Co. KG

Duns Number:317099257

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More Product Details

Catalog Number

-

Brand Name

Freeprint denture pink 385 1.000 g neutral

Version/Model Number

03296

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 22, 2021

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

-

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

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

26749cdd-c755-4917-a884-96a663be854b

Public Version Date

December 23, 2021

Public Version Number

2

DI Record Publish Date

August 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DETAX GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75
2 A medical device with a moderate to high risk that requires special controls. 51