COR-VASC System with articulated arm (Large) 1100229

GUDID 10817121000515

The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The system consists of a large adult sternum retractor, a clamping apparatus, and a coronary artery stabilizer.

Coroneo Inc

Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable

• Primary Device ID: 10817121000515
• NIH Device Record Key: a34baec0-9e90-40eb-80fb-72c1fc014dcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COR-VASC System with articulated arm (Large)
• Version Model Number: 1100229
• Catalog Number: 1100229
• Company DUNS: 255276362
• Company Name: Coroneo Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com
• Phone: 1(514)336-9230
• Email: info@coroneo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817121000515 [Primary]

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

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

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

[10817121000515]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

Devices Manufactured by Coroneo Inc

• 00817121000532 - Spreader arm - Neonate sternum retractor: 2024-02-09 Crank-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
• 00817121000549 - Spreader arm - Neonate sternum retractor: 2024-02-09 Rack-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
• 00817121000556 - Spreader arm - Infant sternum retractor: 2024-02-09 Crank-side spreader arm for the infant pediatric retractor, within separable assembly 1100210 (Infant Pediatric Retractor).
• 00817121000563 - Spreader arm - Infant sternum retractor: 2024-02-09 Rack-side spreader arm for the infant pediatric retractor, within separable assembly 1100210 (Infant Pediatric Retractor).
• 00817121000570 - Pinion for pediatric retractors: 2024-02-09 Pinion for the pediatric retractors, within separable assemblies 1100210 (Infant Pediatric Retractor) and 1100211 (Neonate Pedia
• 10817121000584 - Pediatric sternum retractor, infant: 2024-02-09 Pediatric sternum retractor for the infant patient, comprises two spreader arms and one pinion.
• 10817121000591 - Pediatric sternum retractor, neonate: 2024-02-09 Sternum retractor for neonate patients. Comprises two spreader arms and a pinion.
• 10817121000492 - COR-VALV, Artial tissue retractor system: 2023-07-14 The COR-VALV Atrial retractor system is intended to retract atrial tissue during repair of replacement of the mitral cardiac val