UrgoTul Ag/Silver 8X16 553228

GUDID 00190769532284

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.

URGO MEDICAL NORTH AMERICA, LLC

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• Primary Device ID: 00190769532284
• NIH Device Record Key: 458c059a-a23e-4d15-98c3-926cec4092fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UrgoTul Ag/Silver 8X16
• Version Model Number: 553228
• Catalog Number: 553228
• Company DUNS: 052758618
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190769532284 [Primary]
GS1	10190769532281 [Package]; Package: case [5 Units]; In Commercial Distribution

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

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