Catalog Number

901138

Brand Name

ARAMARK

Version/Model Number

901138

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K943728,K943728,K943728

Product Code

MGQ

Product Code Name

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Public Device Record Key

ed4b48d0-8e40-4f40-ae26-3c1f2adb70ae

Public Version Date

June 09, 2022

Public Version Number

1

DI Record Publish Date

June 01, 2022

Package DI Number

10830868000037

Quantity per Package

125

Contains DI Package

00830868000030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX