Compeed Advanced Blister Care High Heel 8p (oyster) - Blister Support Bandage Cushion - HRA PHARMA AMERICA, INC.

Duns Number:081160441

Device Description: Blister Support Bandage Cushion

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More Product Details

Catalog Number

-

Brand Name

Compeed Advanced Blister Care High Heel 8p (oyster)

Version/Model Number

00810000310180

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

2c032f86-e407-4563-8df1-bf1060d19cf6

Public Version Date

July 13, 2020

Public Version Number

1

DI Record Publish Date

July 04, 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