VascuLoop

GUDID 10803622130844

LIVANOVA USA, INC.

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 10803622130844
• NIH Device Record Key: be2125e4-ce80-4b51-9717-4e2354434fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VascuLoop
• Version Model Number: VascuLoop
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803622130847 [Primary]
GS1	10803622130844 [Package]; Contains: 00803622130847; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122735

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

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: 2019-02-07
• Device Publish Date: 2016-03-15

Devices Manufactured by LIVANOVA USA, INC.

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• 10803622156516 - Cardioplegia Pack: 2024-04-23
• 00803622156526 - Perfusion Pack: 2024-04-23
• 00803622156533 - Perfusion Pack: 2024-04-23
• 00803622156540 - Perfusion Pack: 2024-04-23
• 10803622156554 - Perfusion Pack: 2024-04-23
• 10803622156561 - Perfusion Pack: 2024-04-23
• 10803622156592 - Cardioplegia Pack: 2024-04-23