Catalog Number

9387-00

Brand Name

DeRoyal

Version/Model Number

9387-00

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Public Device Record Key

6407a551-e705-4b45-bc8c-5adaed22d6c0

Public Version Date

August 06, 2021

Public Version Number

1

DI Record Publish Date

July 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-