URGOK2 LITE

Basic Information

• Brand Name: URGOK2 LITE
• Primary DI: 03546890028467
• Version / Model: 553245
• Company Name: LABORATOIRES URGO
• Labeler DUNS: 397310355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-26
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2a7a0fda-e1bc-4793-807a-3d5da0382fc3

Device Description

A 2-layer reduced multicomponent compression bandage system, composed of a short stretch bandage and a long stretch bandage. Layer 1, KTECH Lite/KTECH Reduced composition: wadding: viscose, polyester; knitted layer: polyamide, elastane. Layer 2, KPRESS composition: cotton, polyester, polyamide, elastane; synthetic latex free cohesive material.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58983	Compression bandaging kit	A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03546890028467	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Width of bandages: 4 inches (10 cm)
Device Size Text, specify			For Ankle circumference: 7 1/8 - 9 3/4 inches (18 - 25 cm)
Device Size Text, specify			KTECH (Lite) length = 6.6 yards
Device Size Text, specify			KPRESS length = 7.8 yards stretched

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight