Bioguard Burn Dressing - Ready-Cut Gauze

Basic Information

• Brand Name: Bioguard Burn Dressing - Ready-Cut Gauze
• Primary DI: 00809958088906
• Version / Model: 97118
• Catalog Number: 97118
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-16
• Public Version: 5
• Public Version Date: 2023-10-20
• Public Version Status: Update
• Public Device Record Key: 958cbabf-f7ee-4359-b0f1-26320565125e
• Distribution End Date: 2020-09-09

Device Description

Bioguard Burn Dressing - Ready-Cut Gauze, 100 Ply - Mesh Gauze 18 in x 18 in (45.7 cm x 45.7 cm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYS	Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)	General, Plastic Surgery	878.4015	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62184	Synthetic nanofiber barrier dressing	A sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958088906	GS1
Package	00809958088913	GS1	case	10	Not in Commercial Distribution	2020-09-09

Customer Contacts

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