Dupaque®

Basic Information

• Brand Name: Dupaque®
• Primary DI: 00809958095218
• Version / Model: 9460S
• Catalog Number: DUP9460S
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 16
• Record Status: Published
• Publish Date: 2018-10-17
• Public Version: 2
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: 8543db15-1819-43ef-a2cc-13a0aff61e94

Device Description

3 in X 3 in H-Fold, 12-ply, 20 X 12 mesh gauze X-Ray detectable sponge. Banded. Sterilized.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00809958095225	GS1	Case	8	In Commercial Distribution
Primary	00809958095218	GS1
Unit of Use	00809958095201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3 in X 3 in
Device Size Text, specify			7.5 cm X 7.5 cm