PROMOGRAN PRISMA® - Matrix - SYSTAGENIX WOUND MANAGEMENT, LIMITED

Duns Number:211352227

Device Description: Matrix

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More Product Details

Catalog Number

MA123

Brand Name

PROMOGRAN PRISMA®

Version/Model Number

MA123

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"

-

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 Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

2115d4e0-d8f2-4915-bc20-e64e67469a0a

Public Version Date

October 30, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2019

Additional Identifiers

Package DI Number

25051978002885

Quantity per Package

10

Contains DI Package

15051978002888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SYSTAGENIX WOUND MANAGEMENT, LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
U Unclassified 12