LMI CAROTID ENDARTERECTOMY SHUNT CATHETER

GUDID B38011FCESB300

LUCAS MEDICAL INC

Carotid artery shunt

• Primary Device ID: B38011FCESB300
• NIH Device Record Key: 9ff52f19-3f9c-44da-a47f-67c7cedcdbb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMI CAROTID ENDARTERECTOMY SHUNT CATHETER
• Version Model Number: 11FCESB30
• Company DUNS: 878198993
• Company Name: LUCAS MEDICAL 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B38011FCESB300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983802

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

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

[B38011FCESB300]

Ethylene Oxide

[B38011FCESB300]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

On-Brand Devices [LMI CAROTID ENDARTERECTOMY SHUNT CATHETER]

• B380T39F300: T39F30
• B380T39F150: T39F15
• B380T38F300: T38F30
• B380T38F150: T38F15
• B380T311F300: T311F30
• B380T311F150: T311F15
• B3809FCESB300: 9FCESB30
• B3809FCESB150: 9FCESB15
• B3808FCESB300: 8FCESB30
• B3808FCESB150: 8FCESB15
• B38012FCESB300: 12FCESB30
• B38012FCESB150: 12FCESB15
• B38011FCESB300: 11FCESB30
• B38011FCESB150: 11FCESB15
• B38010FCESB300: 10FCESB30
• B38010FCESB150: 10FCESB15