AnastoClip GC 8cm (XLarge) 4008-08

GUDID 00840663109593

AnastoClip GC 8cm (XLarge)

Lemaitre Vascular, Inc.

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• Primary Device ID: 00840663109593
• NIH Device Record Key: abe2edb9-cf84-4b1d-90c4-99b07aed3ad3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnastoClip GC 8cm (XLarge)
• Version Model Number: 4008-08
• Catalog Number: 4008-08
• Company DUNS: 184805166
• Company Name: Lemaitre Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663109593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091987

FDA Product Code

• FZP: Clip, Implantable

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: 2021-06-28
• Device Publish Date: 2021-06-18

Devices Manufactured by Lemaitre Vascular, Inc.

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• 00840663108718 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 12cm x 25cm
• 00840663108787 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm
• 00840663108794 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 5cm x 10cm
• 00840663108800 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 12cm x 25cm
• 00840663108824 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 5cm x 10cm, eIFU
• 00840663108831 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm, eIFU
• 00840663108916 - YES Tape: 2021-06-28 YES Tape