Catalog Number

46-927

Brand Name

DeRoyal

Version/Model Number

46-927

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"

Yes

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

-

Product Code

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

6910e3a7-5966-4528-bf48-f413d7ac8d9a

Public Version Date

September 22, 2021

Public Version Number

1

DI Record Publish Date

September 14, 2021

Package DI Number

30749756897809

Quantity per Package

10

Contains DI Package

00749756897808

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box