Flouropassiv™ 921015FT

GUDID 05037881011097

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH

VASCUTEK LTD

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 05037881011097
• NIH Device Record Key: 32f6fe5d-9ca7-450d-a052-81044ca6430a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flouropassiv™
• Version Model Number: 921015FT
• Catalog Number: 921015FT
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx
• Phone: +1(800)262-3304
• Email: xx@xx.xx

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
• 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 in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry area at room temperature. Prostheses must be implanted within one month after removal from the foil pouch.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881011097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972201

FDA Product Code

• DXZ: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-14
• Device Publish Date: 2015-10-22

On-Brand Devices [Flouropassiv™]

• 05037881011103: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011097: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011080: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011073: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011066: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011059: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011042: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011035: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011028: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881011011: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
• 05037881003238: Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch VS125 TAPERED PATCH