Latis Silicone Graft Cleaning Catheter A4GW6

GUDID 00840663109975

Latis Silicone Graft Cleaning Catheter

Lemaitre Vascular, Inc.

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• Primary Device ID: 00840663109975
• NIH Device Record Key: 65764429-1b66-482c-b6f6-69103061e23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Latis Silicone Graft Cleaning Catheter
• Version Model Number: A4GW6
• Catalog Number: A4GW6
• 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: 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
• 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 Dimensions

• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663109975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973465

FDA Product Code

• DXE: Catheter, Embolectomy

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

On-Brand Devices [Latis Silicone Graft Cleaning Catheter]

• 00840663109975: Latis Silicone Graft Cleaning Catheter
• 00840663109968: Latis Silicone Graft Cleaning Catheter
• 00840663109951: Latis Silicone Graft Cleaning Catheter