Derma

Basic Information

• Brand Name: Derma
• Primary DI: 00809958000328
• Version / Model: 9004X
• Catalog Number: DUP9004X
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 3
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: a8395f78-3ab4-4213-a8b7-dde325b9ba14

Device Description

2 in X 100 yards, X-Ray detectable surgical gauze packing, made from 28 X 24 mesh gauze, 4-Ply.

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: No
• 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
48128	Gauze strip, non-antimicrobial	A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958000328	GS1
Unit of Use	00809958000700	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2 in X 100 yards
Device Size Text, specify			5.08 cm X 91.4 m