ProCol Biologic Vascular Graft HJL016-10-N

GUDID 00840663108657

ProCol Biologic Vascular Graft, 6mm x 10 cm

LEMAITRE VASCULAR, INC.

Arteriovenous shunt

• Primary Device ID: 00840663108657
• NIH Device Record Key: 05f6531b-7ed2-4125-af0f-c1ca92c72c4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCol Biologic Vascular Graft
• Version Model Number: HJL016-10-N
• Catalog Number: HJL016-10-N
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663108657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020049

FDA Product Code

• LXA: Tissue Graft Of 6mm And Greater

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: 2018-07-06
• Device Publish Date: 2016-03-22

On-Brand Devices [ProCol Biologic Vascular Graft]

• 00840663108688: ProCol Biologic Vascular Graft, 6mm x 40 cm
• 00840663108671: ProCol Biologic Vascular Graft, 6mm x 30 cm
• 00840663108664: ProCol Biologic Vascular Graft, 6mm x 25 cm
• 00840663108657: ProCol Biologic Vascular Graft, 6mm x 10 cm