Garfield - Adhesive Bandages, sterile spots, 7/8 IN (22 mm) - Aso LLC

Duns Number:152793493

Device Description: Adhesive Bandages, sterile spots, 7/8 IN (22 mm)

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More Product Details

Catalog Number

GAR5561

Brand Name

Garfield

Version/Model Number

017276222265

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

b0da9490-a386-447b-be04-db2c7bbcd4e1

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 20, 2020

Additional Identifiers

Package DI Number

20017276222269

Quantity per Package

12

Contains DI Package

00017276222265

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