Catalog Number

AMS-9055CP

Brand Name

VYGON

Version/Model Number

AMS-9055CP

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing change tray

Public Device Record Key

2b1bcd2b-12fd-45e1-a3ca-e7643a00ba40

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 2020

Package DI Number

30849884001243

Quantity per Package

20

Contains DI Package

00849884001242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-