SCAR AID - Scar Aid Fabric Areola Circles, 3" x 0.75", 5 Pair - BIODERMIS CORPORATION

Duns Number:809650005

Device Description: Scar Aid Fabric Areola Circles, 3" x 0.75", 5 Pair

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More Product Details

Catalog Number

SFAC-51

Brand Name

SCAR AID

Version/Model Number

SFAC-51

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K992146

Product Code Details

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Device Record Status

Public Device Record Key

85a98a5e-6253-4285-aaa9-134dfb0de3c5

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIODERMIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 182