CGuard Prime Carotid Stent System CND0830

GUDID 07290120281899

CGuard Prime Carotid Stent System 135cm, 8mmx30mm

INSPIRE M.D LTD

Mesh-sleeve carotid artery stent

• Primary Device ID: 07290120281899
• NIH Device Record Key: b8510040-0610-4198-95d2-f42707ba308b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CGuard Prime Carotid Stent System
• Version Model Number: CND0830
• Catalog Number: CND0830
• Company DUNS: 514477996
• Company Name: INSPIRE M.D LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290120281691 [Primary]
GS1	07290120281899 [Package]; Contains: 07290120281691; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240029

FDA Product Code

• NIM: Stent, Carotid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-10
• Device Publish Date: 2025-07-02

On-Brand Devices [CGuard Prime Carotid Stent System]

• 07290120281981: CGuard Prime Carotid Stent System 135cm,10mmx40mm
• 07290120281974: CGuard Prime Carotid Stent System 135cm,10mmx30mm
• 07290120281943: CGuard Prime Carotid Stent System 135cm, 9mmx40mm
• 07290120281936: CGuard Prime Carotid Stent System 135cm, 9mmx30mm
• 07290120281905: CGuard Prime Carotid Stent System 135cm, 8mmx40mm
• 07290120281899: CGuard Prime Carotid Stent System 135cm, 8mmx30mm