DeRoyal - NEOPRENE WRAP - DEROYAL INDUSTRIES, INC.

Duns Number:096372255

Device Description: NEOPRENE WRAP

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More Product Details

Catalog Number

9361-00

Brand Name

DeRoyal

Version/Model Number

9361-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MHW

Product Code Name

DRESSING, COMPRESSION

Device Record Status

Public Device Record Key

3e0ea86f-3391-4269-8b58-69ea5bf33cfc

Public Version Date

August 06, 2021

Public Version Number

1

DI Record Publish Date

July 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEROYAL INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7041
2 A medical device with a moderate to high risk that requires special controls. 4913
U Unclassified 3