Compeed Advanced Blister Care Mixed Size (6+4+2) 12p - Blister Support Bandage Cushion - HRA PHARMA AMERICA, INC.

Duns Number:081160441

Device Description: Blister Support Bandage Cushion

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Compeed Advanced Blister Care Mixed Size (6+4+2) 12p

Version/Model Number

00810000318001

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)

-

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

466cd99f-2c03-44e5-a65b-2aa1e4af355b

Public Version Date

November 25, 2020

Public Version Number

1

DI Record Publish Date

November 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HRA PHARMA AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31