UrgoTul Ag/Silver

Basic Information

• Brand Name: UrgoTul Ag/Silver
• Primary DI: 00190769532284
• Version / Model: 553228
• Catalog Number: 553228
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Labeler DUNS: 052758618
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-03
• Public Version: 3
• Public Version Date: 2020-09-11
• Public Version Status: Update
• Public Device Record Key: 458c059a-a23e-4d15-98c3-926cec4092fc

Device Description

Contact Layer Silver is a non-adhesive, non-occlusive, antimicrobial wound contact dressing, composed of a polyester mesh impregnated with a matrix of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petrolatum and silver. Not made with natural rubber.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
47042	Wound-nonadherent dressing, absorbent, antimicrobial	A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190769532284	GS1
Package	10190769532281	GS1	case	5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 X 16 inches

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Store away from light.