TURBO TEMP 2 - TURBO TEMP2,A1,FA - DANVILLE MATERIALS, LLC

Duns Number:601302743

Device Description: TURBO TEMP2,A1,FA

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More Product Details

Catalog Number

90156

Brand Name

TURBO TEMP 2

Version/Model Number

90156

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

-

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

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Device Record Status

Public Device Record Key

f2e7b6c6-688c-4ed1-875e-238dbf7888d4

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

June 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DANVILLE MATERIALS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 223