UrgoTul Absorb Border

Basic Information

• Brand Name: UrgoTul Absorb Border
• Primary DI: 00190769507633
• Version / Model: 550763
• Catalog Number: 550763
• 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: 2019-03-01
• Public Version: 5
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 01ac61ab-99cb-468e-9da3-315cf6d07ca5

Device Description

A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges.

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43186	Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, 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	10190769507630	GS1		8	In Commercial Distribution
Primary	00190769507633	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 X 6 inches

Storage Conditions

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