DERMAGRAN®

Basic Information

• Brand Name: DERMAGRAN®
• Primary DI: 10753567250032
• Version / Model: DH-03
• Catalog Number: DERMA-DH03
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-03-15
• Public Version: 2
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 9fa8e5c3-d28b-4b18-a258-24c110769808

Device Description

Dermagran Amorphous Hydrogel

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, wound, hydrogel without drug and/or biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10753567250032	GS1
Unit of Use	00753567250035	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			85 g
Device Size Text, specify			3 oz

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius