FDA.reportPublic FDA data

Spreader arm - Neonate sternum retractor

Primary DI
00817121000549
Brand
Spreader arm - Neonate sternum retractor
Company
Coroneo Inc
Model
1010837
Catalog number
1010837
Device description
Rack-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
Published
2024-02-01
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817121000549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817121000549008171210005498171210005490817121000549

GMDN Terms#

Term, Definition table
TermDefinition
Sternum spreaderA self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device.

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
Serial number
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
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
10817121000485Swift Loop101105810110582023-06-28

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Primary DI, Brand, Company table
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B382SD907394200Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD914172160Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141731000Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141781300Surgical DirectSurgical Direct, Inc.GAD2026-07-24
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