URGOK2 Lite (Long) Kit 553246

GUDID 10190769532465

URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place. URGOK2 Lite is for the treatment of venous or mixed leg ulcers, venous edema and lymphedema, which require a reduced level of compression. Not made with natural rubber latex.

URGO MEDICAL NORTH AMERICA, LLC

Compression bandaging kit

• Primary Device ID: 10190769532465
• NIH Device Record Key: 2a19d545-a82d-4a24-8c50-c857332f5426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URGOK2 Lite (Long) Kit
• Version Model Number: 553246
• Catalog Number: 553246
• Company DUNS: 052758618
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com
• Phone: 855-888-8273
• Email: info@us.urgo.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190769532468 [Primary]
GS1	10190769532465 [Package]; Contains: 00190769532468; Package: Case [27 Units]; In Commercial Distribution

FDA Product Code

• FQM: Bandage, Elastic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-20
• Device Publish Date: 2019-12-20

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• 10190769532465 - URGOK2 Lite (Long) Kit: 2020-02-20URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and absorbency and KPRESS: a cohesive long-stretch bandage providing the additional compression necessary to achieve therapeutic pressure and secure the bandages in place. URGOK2 Lite is for the treatment of venous or mixed leg ulcers, venous edema and lymphedema, which require a reduced level of compression. Not made with natural rubber latex.
• 10190769532465 - URGOK2 Lite (Long) Kit: 2020-02-20 URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and a