FDA.reportPublic FDA data

COR-VALV Aortic retractor cables with fitting

Primary DI
00817121000204
Brand
COR-VALV Aortic retractor cables with fitting
Company
Coroneo Inc
Model
1011181
Catalog number
1011181
Device description
Single-use cables for use with the COR-VALV aortic retractor 1010676.
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817121000201PrimaryGS10
00817121000204Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712100020110817121000201
00817121000204008171210002048171210002040817121000204

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5143369230info@coroneo.com

Regulatory Flags#

DUNS number
255276362
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
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00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12