Syntel Silicone Embolectomy Catheter A4F01

GUDID 00840663109623

Syntel Silicone Embolectomy Catheter - Spring Tip

Lemaitre Vascular, Inc.

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• Primary Device ID: 00840663109623
• NIH Device Record Key: 65baecd6-ed97-4d84-b1a9-e1e0ec022e07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntel Silicone Embolectomy Catheter
• Version Model Number: A4F01
• Catalog Number: A4F01
• 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 Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter
• Catheter Length: 80 Centimeter
• Catheter Gauge: 2 French
• Total Volume: 0.08 Milliliter

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	00840663109623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901627

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 [Syntel Silicone Embolectomy Catheter]

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• 00840663109678: Syntel Silicone Embolectomy Catheter
• 00840663109661: Syntel Silicone Embolectomy Catheter - Spring Tip
• 00840663109654: Syntel Silicone Embolectomy Catheter - Spring Tip
• 00840663109647: Syntel Silicone Embolectomy Catheter - Spring Tip
• 00840663109630: Syntel Silicone Embolectomy Catheter - Spring Tip
• 00840663109623: Syntel Silicone Embolectomy Catheter - Spring Tip
• 00840663109616: Syntel Silicone Embolectomy Catheter - Spring Tip