Axcent Acrylics - #1 HC 4oz - GARRECO, LLC

Duns Number:364004762

Device Description: #1 HC 4oz

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More Product Details

Catalog Number

3780004

Brand Name

Axcent Acrylics

Version/Model Number

3780004

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)

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

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

9c8b493e-600f-4cbf-8b0a-2ebcba5e4f4c

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 25, 2016

Additional Identifiers

Package DI Number

D79337800041

Quantity per Package

4

Contains DI Package

D79337800040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GARRECO, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 134