View Guard Transparent Film Dressing Roll - View Guard Transparent Film Dressing Roll; - DYNAREX CORPORATION

Duns Number:008124539

Device Description: View Guard Transparent Film Dressing Roll; Semi-Permeable, Non-Sterile, 4"x11yds

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


More Product Details

Catalog Number

-

Brand Name

View Guard Transparent Film Dressing Roll

Version/Model Number

3640

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

6f35393d-9956-4548-8ed6-a86740bcdf14

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Additional Identifiers

Package DI Number

00616784364032

Quantity per Package

12

Contains DI Package

00616784364018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2