Dupaque® - 4 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze - Derma Sciences Canada Inc

Duns Number:200564891

Device Description: 4 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 10s. Ste 4 in X 4 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded in 10s. Sterilized.

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More Product Details

Catalog Number

DUP9463S

Brand Name

Dupaque®

Version/Model Number

9463S

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)

-

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

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Device Record Status

Public Device Record Key

20cfee0f-6024-4518-b719-daa02e644402

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

October 17, 2018

Additional Identifiers

Package DI Number

00809958093023

Quantity per Package

8

Contains DI Package

00809958093016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DERMA SCIENCES CANADA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 254
2 A medical device with a moderate to high risk that requires special controls. 15
U Unclassified 42