CERENOVUS ENTERPRISE ENF453712

GUDID 10886704044048

CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 37mm. 12mm Distal tip. Maximum Stent foreshortening 4.7mm, Recommended Microcatheter .021inch(0.533mm)

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 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 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: 10886704044048
• NIH Device Record Key: 0c250d19-eb9e-4039-be24-c4a1d9fab41f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERENOVUS ENTERPRISE
• Version Model Number: ENF453712
• Catalog Number: ENF453712
• 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
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if opened or damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704044048 [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: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-20

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