Flexcel Carotid Shunt 2020-15

GUDID 00840663101368

Flexcel Carotid Shunt (8F)

LEMAITRE VASCULAR, INC.

Carotid artery shunt

• Primary Device ID: 00840663101368
• NIH Device Record Key: 63aa2e63-f7cc-4388-98d2-b69a8c6cd9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexcel Carotid Shunt
• Version Model Number: 2020-15
• Catalog Number: 2020-15
• 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	00840663101351 [Unit of Use]
GS1	00840663101368 [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)