SILVAPRO

Basic Information

• Brand Name: SILVAPRO
• Primary DI: 15060206630274
• Version / Model: FG08825191
• Catalog Number: FG08825191
• Company Name: MEDTRADE PRODUCTS LIMITED
• Labeler DUNS: 238476068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-30
• Public Version: 1
• Public Version Date: 2021-10-08
• Public Version Status: New
• Public Device Record Key: 821275c0-3ae4-4ff7-84fc-c91666cd6da2

Device Description

Antibacterial Burn Dressing: For the Pre-Hospital Management of 1st and 2nd Degree Burns with Aquanova Ag Technology Each dressing contains nominally 0.75% by weight of ionic silver

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: No
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35060206630278	GS1	Inner Case	25	In Commercial Distribution
Primary	15060206630274	GS1
Package	75060206630276	GS1	Shipper Case	6	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5in by 9in Dressing
Width	5	Inch
Length	9	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 40 Degrees Celsius