Catalog Number

MA028

Brand Name

PROMOGRAN PRISMA®

Version/Model Number

MA028

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

fb7cd142-64fd-4748-a14b-3795190796a7

Public Version Date

October 30, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2019

Package DI Number

25051978002830

Quantity per Package

10

Contains DI Package

15051978002833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-