FDA.reportPublic FDA data

COR-VASC System with articulated arm (Large)

Primary DI
10817121000515
Brand
COR-VASC System with articulated arm (Large)
Company
Coroneo Inc
Model
1100229
Catalog number
1100229
Device description
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.
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817121000515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081712100051510817121000515

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(514)336-9230info@coroneo.com

Regulatory Flags#

DUNS number
255276362
Device count
1
Premarket exempt
true
Kit
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817121000171Aortic Prosthesis Indexing Cone101060510106052022-09-28
00817121000532Spreader arm - Neonate sternum retractor101083510108352024-02-01
00817121000549Spreader arm - Neonate sternum retractor101083710108372024-02-01
00817121000556Spreader arm - Infant sternum retractor101084210108422024-02-01
00817121000563Spreader arm - Infant sternum retractor101084410108442024-02-01
00817121000570Pinion for pediatric retractors101085010108502024-02-01
10817121000584Pediatric sternum retractor, infant110021011002102024-02-01
10817121000591Pediatric sternum retractor, neonate110021111002112024-02-01
10817121000492COR-VALV, Artial tissue retractor system110004111000412023-07-06
10817121000508COR-VALV Atrial tissue retractor system110004211000422023-07-06
10817121000522COR-VASC System with articulated arm (Small)110023011002302023-07-06
10817121000201COR-VALV Aortic retractor cables with fitting101118110111812023-06-30
10817121000393COR-VALV Intercostal retractor cable101173910117392023-06-30
00817121000204COR-VALV Aortic retractor cables with fitting101118110111812023-06-30
00817121000396COR-VALV Intercostal retractor cable101173910117392023-06-30
00817121000433COR-VASC Articulated arm clamping system110034911003492023-06-28
10817121000317Pinion - Large101171310117132022-09-29
10817121000461Swift Loop101064310106432023-06-28
10817121000478Swift Loop101081510108152023-06-28
10817121000485Swift Loop101105810110582023-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
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00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14
03661219510970LANDANGERLANDANGERDWS2026-07-12
03661219512660DELACROIX-CHEVALIERLANDANGERDWS2026-07-12
03661219528371LANDANGERLANDANGERDWS2026-07-12
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08