FDA.reportPublic FDA data

Stabilizer for articulated arm

Primary DI
00817121000181
Brand
Stabilizer for articulated arm
Company
Coroneo Inc
Model
1010771
Catalog number
1010771
Device description
Intended Use: The CORVASC coronary artery stabilizers with articulated arm are intended to be used during coronary artery bypass surgery to reduce the mobility of cardiac tissue around a targeted graft site on a beating or arrested heart.
Published
2023-06-28
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
10817121000188PackageGS11In Commercial Distribution
00817121000181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712100018810817121000188
00817121000181008171210001818171210001810817121000181

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5143369230info@coroneo.com

Regulatory Flags#

DUNS number
255276362
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
10817121000515COR-VASC System with articulated arm (Large)110022911002292023-07-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M944TL034010Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034110Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034310Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034410Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034510Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034610Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034710Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034810Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL034910Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL036110Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL044610Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL044710Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL072010Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
M944TL072210Wexler Surgical, Inc.WEXLER SURGICAL, INC.DWS2026-10-30
B382SD903260200Surgical DirectSurgical Direct, Inc.DWS2026-10-28
00724995264819Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264826Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264833Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264840Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264857Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265564Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265571Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265588Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995278977V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279004V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279042V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279059V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279066V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279080V. MuellerSTERIS Deutschland GmbHDWS2026-10-27