Catalog Number

AMS-9788CP-3

Brand Name

VYGON

Version/Model Number

AMS-9788CP-3

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

57fbdb8d-832c-4c3f-b8e6-62adb8fa1236

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

November 14, 2017

Package DI Number

38498840011257

Quantity per Package

20

Contains DI Package

08498840011256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-