Pruitt F3 Carotid Shunt e2012-12

GUDID 00840663101306

9F Pruitt F3 Inlying Shunt with T-port, eIFU

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: 00840663101306
• NIH Device Record Key: 6694f618-9d15-490f-a5a4-7abd9728432e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pruitt F3 Carotid Shunt
• Version Model Number: e2012-12
• Catalog Number: e2012-12
• 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: false
• 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: 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	00840663101306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051067

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 [Pruitt F3 Carotid Shunt]

• 00840663101320: 8F Pruitt F3 Outlying Shunt with T-port, eIFU
• 00840663101313: 9F Pruitt F3 Inlying Shunt without T-port, eIFU
• 00840663101306: 9F Pruitt F3 Inlying Shunt with T-port, eIFU
• 00840663101290: 9F Pruitt F3 Outlying Shunt without T-port, eIFU
• 00840663101283: 9F Pruitt F3 Outlying Shunt with T-port, eIFU
• 00840663101276: 10F Pruitt F3 inlying Shunt with T-port, eIFU
• 00840663101269: 10F Pruitt F3 Outlying Shunt with T-port, eIFU
• 00840663101252: 8F Pruitt F3 Outlying Shunt with T-port
• 00840663101245: 9F Pruitt F3 Inlying Shunt without T-port
• 00840663101238: 9F Pruitt F3 Inlying Shunt with T-port
• 00840663101221: 9F Pruitt F3 Outlying Shunt without T-port
• 00840663101214: 9F Pruitt F3 Outlying Shunt with T-port
• 00840663101207: 10F Pruitt F3 inlying Shunt with T-port
• 00840663101191: 10F Pruitt F3 Outlying Shunt with T-port