Derma

Basic Information

• Brand Name: Derma
• Primary DI: 00809958014417
• Version / Model: 11912
• Catalog Number: 11912
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2022-10-25
• Public Version Status: Update
• Public Device Record Key: e7d8c083-b61a-4f84-b446-5a0d36123f3a

Device Description

40 in X 40 in Triangular Bandage with 2 pins

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: No
• 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
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46325	Elevation arm sling	A non-sterile hanging band intended to immobilize an injured arm, that is typically suspended from an overhead support. It is designed to elevate the extremity to aid in controlling oedema, enhancing recovery typically following hand or forearm surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958014417	GS1
Unit of Use	00809958014400	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			40 in X 40 in X 56 in
Device Size Text, specify			102 cm X 102 cm X 142 cm