FREEPRINT temp A2 385 1000g - DETAX GmbH & Co. KG

Duns Number:317099257

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More Product Details

Catalog Number

-

Brand Name

FREEPRINT temp A2 385 1000g

Version/Model Number

02130

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

-

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

8c936025-f201-4647-9ac1-9f85d42d74d4

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

January 15, 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