Dermapac, Inc. - Full Head Dressing - Dermapac Inc.

Duns Number:796088466

Device Description: Full Head Dressing

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More Product Details

Catalog Number

-

Brand Name

Dermapac, Inc.

Version/Model Number

9209

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"

-

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 Details

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Device Record Status

Public Device Record Key

6bd80c16-4cc6-4f19-854b-72a7783bdcb1

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMAPAC INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 178