Syntel Silicone OTW Embolectomy Catheter A4E01

GUDID 00840663109869

Syntel Silicone OTW Embolectomy Catheter

Lemaitre Vascular, Inc.

Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter

• Primary Device ID: 00840663109869
• NIH Device Record Key: d67d448c-4221-4ebc-a759-1669161aa97a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntel Silicone OTW Embolectomy Catheter
• Version Model Number: A4E01
• Catalog Number: A4E01
• 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: true
• 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: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter
• Catheter Working Length: 40 Centimeter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663109869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970762

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 OTW Embolectomy Catheter]

• 00840663109944: Syntel Silicone OTW Embolectomy Catheter
• 00840663109937: Syntel Silicone OTW Embolectomy Catheter
• 00840663109920: Syntel Silicone OTW Embolectomy Catheter
• 00840663109913: Syntel Silicone OTW Embolectomy Catheter
• 00840663109906: Syntel Silicone OTW Embolectomy Catheter
• 00840663109890: Syntel Silicone OTW Embolectomy Catheter
• 00840663109883: Syntel Silicone OTW Embolectomy Catheter
• 00840663109876: Syntel Silicone OTW Embolectomy Catheter
• 00840663109869: Syntel Silicone OTW Embolectomy Catheter