SILVEX

Basic Information

• Brand Name: SILVEX
• Primary DI: 00020424321949
• Version / Model: 03COM21094; 03HBC21094NEW; 03HBC21094NEWWAG; 03HBC21094NEWWM
• Company Name: TOTAL RESOURCES INTERNATIONAL INC.
• Labeler DUNS: 790160535
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-05
• Public Version: 2
• Public Version Date: 2024-01-29
• Public Version Status: Update
• Public Device Record Key: 6736a148-be36-4a96-a7bb-45f04b04caf7

Device Description

Silvex Wound Gel 0.5 oz Wound Care, All Purpose - (1) Silvex First Aid Gel 0.5 oz (14 g)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, 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. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00020424321949	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140483	000

Device Sizes

Type	Value	Unit	Text
Weight	14	Gram