FDA.reportPublic FDA data

Pediatric sternum retractor, neonate

Primary DI
10817121000591
Brand
Pediatric sternum retractor, neonate
Company
Coroneo Inc
Model
1100211
Catalog number
1100211
Device description
Sternum retractor for neonate patients. Comprises two spreader arms and a pinion.
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
10817121000591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081712100059110817121000591

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437398MillenniumAvalign Technologies, Inc.GAD2026-11-02
00190776437442MillenniumAvalign Technologies, Inc.GAD2026-11-02
G383S1084WM853543327SURJEXSURJEXGAD2026-10-31
G383S1084WM98733224SURJEXSURJEXGAD2026-10-31
G383S1084WM98733234SURJEXSURJEXGAD2026-10-31
G383S1084WM9873329SURJEXSURJEXGAD2026-10-31
G383S10937044323SURJEXSURJEXGAD2026-10-31
G383S10937044343SURJEXSURJEXGAD2026-10-31
G383S10937044353SURJEXSURJEXGAD2026-10-31
G383S1093WM96712533SURJEXSURJEXGAD2026-10-31
G383S1093WM9671255SURJEXSURJEXGAD2026-10-31
G383S1094112182SURJEXSURJEXGAD2026-10-31
G383S1094112192SURJEXSURJEXGAD2026-10-31
G383S1094112202SURJEXSURJEXGAD2026-10-31
G383S1094WM1867025SURJEXSURJEXGAD2026-10-31
G383S1094WM1867125SURJEXSURJEXGAD2026-10-31
G383S1094WM88672125SURJEXSURJEXGAD2026-10-31
G383S10981124048SURJEXSURJEXGAD2026-10-31
G383S1098112424SURJEXSURJEXGAD2026-10-31
G383S1098112444SURJEXSURJEXGAD2026-10-31
00190776437275MillenniumAvalign Technologies, Inc.GAD2026-10-30
00190776437282MillenniumAvalign Technologies, Inc.GAD2026-10-30
00840329838744BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAD2026-10-30
B382SD914178350Surgical DirectSurgical Direct, Inc.GAD2026-10-30
00190776439811MilleniumAvalign Technologies, Inc.GAD2026-10-28
B382SD907310080Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD9141781200Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD91417912190Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B8039018650ORTHOMEDORTHO-MED, INC.GAD2026-10-27
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26