SMITHWICK Carotid Shunt SDS1014JT

GUDID 00858764006154

Doppler Carotid Shunt 14 Fr. To 9 Fr., With “T” port, 11” long

Implantable Devices

Carotid artery shunt

• Primary Device ID: 00858764006154
• NIH Device Record Key: de0d9d76-2b37-4cbb-8235-0e197c34d3f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMITHWICK Carotid Shunt
• Version Model Number: SDS1014JT
• Catalog Number: SDS1014JT
• Company DUNS: 081364911
• Company Name: Implantable Devices
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 727-526-9159
• Email: implantabledevices@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858764006154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021608

FDA Product Code

• DXC: Clamp, Vascular

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: 2016-10-24

On-Brand Devices [SMITHWICK Carotid Shunt]

• 00858764006222: Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Distal Balloon with safety balloon
• 00858764006215: Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Non Reinforced Segment
• 00858764006208: Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long
• 00858764006192: Carotid Shunt 14 Fr To 10 Fr, wire reinforced, 13cm long
• 00858764006185: Two 15cm, tapered, carotid shunts. One 1408 shunt (14 Fr. to 8 Fr.) and one 1209 shunt (12 Fr. t
• 00858764006178: Doppler Carotid Shunt 12 Fr. To 9 Fr. With “T” port, 15 cm long
• 00858764006161: Doppler Carotid Shunt 12 Fr. To 9 Fr., 15 cm long
• 00858764006154: Doppler Carotid Shunt 14 Fr. To 9 Fr., With “T” port, 11” long
• 00858764006147: Doppler Carotid Shunt 14 Fr. To 9 Fr., 11” long
• 00858764006130: Carotid Shunt 12 Fr. To 9 Fr. With “T” port, 15 cm long
• 00858764006123: Carotid Shunt 14 Fr. To 9 Fr., With “T” port, 11” long
• 00858764006116: Carotid Shunt 14 Fr. To 9 Fr., 11” long
• 00858764006109: Doppler Carotid Shunt 14 Fr. To 8 Fr., 15 cm long
• 00858764006093: Doppler Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Distal Balloon with safety b
• 00858764006086: Doppler Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Non Reinforced Segment
• 00858764006079: Doppler Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long
• 00858764006062: Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon and T-port
• 00858764006055: Carotid Shunt 9 Fr., dual balloon, 15 cm long, with safety balloon and T-port
• 00858764006048: Doppler Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon
• 00858764006031: Doppler Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon and T-port
• 00858764006024: Doppler Carotid Shunt 14 Fr To 10 Fr, wire reinforced, 13cm long
• 00858764006017: Carotid Shunt 9 Fr., dual balloon, 15 cm long, with safety balloon
• 00858764006000: Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon