ALL-HEALTH Hydrocolloid Gel Bandages - Fast-healing Hydrocolloid Gel Bandages, 19 mm x - Aso LLC

Duns Number:152793493

Device Description: Fast-healing Hydrocolloid Gel Bandages, 19 mm x 73 mm

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More Product Details

Catalog Number

017276233858

Brand Name

ALL-HEALTH Hydrocolloid Gel Bandages

Version/Model Number

017276233858

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

c2911eb7-de7c-45c2-955d-8ea805699966

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

March 29, 2019

Additional Identifiers

Package DI Number

20017276233852

Quantity per Package

72

Contains DI Package

00017276233858

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