CERENOVUS ENTERPRISE ENF402300

GUDID 10886704075363

CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 23 NO DISTAL TIP Recommended Microcatheter .021 Inch (0.533mm) Maximum Stent Foreshortening 2.0 mm Humanitarian Device USA ONLY): Authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4mm. Wide-neck is defined as having a neck width greater than or equal to 4mm or a dome-to-neck ratio less than 2mm. The effectiveness of this device for this use has not been demonstrated.

Medos International Sàrl

Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent

• Primary Device ID: 10886704075363
• NIH Device Record Key: 10163adb-c627-406c-a5c6-84c53e4d274e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERENOVUS ENTERPRISE
• Version Model Number: ENF402300
• Catalog Number: ENF402300
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704075363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H060001

FDA Product Code

• NJE: intracranial neurovascular stent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-29
• Device Publish Date: 2015-11-16

On-Brand Devices [CERENOVUS ENTERPRISE]

• 10886704075400: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 39 NO
• 10886704075394: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 39 Rec
• 10886704075387: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 30 NO
• 10886704075370: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 30 Rec
• 10886704075363: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 23 NO
• 10886704075356: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 23 Rec
• 10886704075349: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 16 NO
• 10886704075332: CERENOVUS ENTERPRISE 2 Vascular Reconstruction Device Stent OD (mm) 4.0 Stent Length (mm) 16 Rec
• 10886704071808: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704071785: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704071761: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704071747: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704044048: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704044031: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704044024: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4
• 10886704044017: CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4