UrgoCell Ag/ Silver Foam 6 X 8 509346

GUDID 10190769093461

A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing.

URGO MEDICAL NORTH AMERICA, LLC

Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 10190769093461
• NIH Device Record Key: 25e9fae1-c403-4bba-863f-19ea1dcb970f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UrgoCell Ag/ Silver Foam 6 X 8
• Version Model Number: 509346
• Catalog Number: 509346
• 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: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• Email: info@us.urgo.com
• Phone: 885-888-8273
• 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 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190769093464 [Primary]
GS1	10190769093461 [Package]; Contains: 00190769093464; Package: [4 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-25
• Device Publish Date: 2019-03-01

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