CARE SCIENCE - Finger & Toe Smart-Heal Hydrocolloid Gel - Aso LLC

Duns Number:152793493

Device Description: Finger & Toe Smart-Heal Hydrocolloid Gel Bandages, assorted sizes

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More Product Details

Catalog Number

017276234763

Brand Name

CARE SCIENCE

Version/Model Number

017276234763

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"

Yes

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

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

a3ccc125-d7c8-4ad3-82c2-551597c12eef

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

April 26, 2019

Additional Identifiers

Package DI Number

20017276234767

Quantity per Package

72

Contains DI Package

00017276234763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ASO LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 4
U Unclassified 1