Anscare LeniScar Silicone Stick - Anscare Leniscar Silicone Stick provides an - BENQ MATERIALS CORP.

Duns Number:657476292

Device Description: Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. It is inte

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More Product Details

Catalog Number

-

Brand Name

Anscare LeniScar Silicone Stick

Version/Model Number

SP-14-1112

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MDA

Product Code Name

Elastomer, Silicone, For Scar Management

Device Record Status

Public Device Record Key

2bf463c8-77d2-4305-8aa2-19f0b7516361

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BENQ MATERIALS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 12