Flexcel Carotid Shunt 2020-45

GUDID 00840663101429

Flexcel Carotid Shunt (14F)

LEMAITRE VASCULAR, INC.

Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt Carotid artery shunt

• Primary Device ID: 00840663101429
• NIH Device Record Key: ca95ea64-d572-4c45-93bf-89022d394be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexcel Carotid Shunt
• Version Model Number: 2020-45
• Catalog Number: 2020-45
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, INC.
• Device Count: 5
• 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

Customer Support Contacts

• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663101412 [Unit of Use]
GS1	00840663101429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071367

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-30

On-Brand Devices [Flexcel Carotid Shunt]

• 00840663101429: Flexcel Carotid Shunt (14F)
• 00840663101405: Flexcel Carotid Shunt (12F)
• 00840663101382: Flexcel Carotid Shunt (10F)
• 00840663101368: Flexcel Carotid Shunt (8F)
• 00840663101344: Flexcel Carotid Shunt (8F, 10F, 12F, 14F)