COR-VASC Articulated Arm Clamp Base 1011593

GUDID 10817121000423

The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The Articulated Arm Clamp Base is intended to be used together with the Articulated Arm components 1011592 and 1010937.

Coroneo Inc

Surgical retraction system, reusable
Primary Device ID10817121000423
NIH Device Record Key9e2420e2-7ade-479b-aba8-e1cbac2a0b76
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOR-VASC Articulated Arm Clamp Base
Version Model Number1011593
Catalog Number1011593
Company DUNS255276362
Company NameCoroneo Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com
Phone5143369230
Emailinfo@coroneo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817121000426 [Primary]
GS110817121000423 [Package]
Contains: 00817121000426
Package: box [1 Units]
In Commercial Distribution

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


[10817121000423]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-06
Device Publish Date2023-06-28

Devices Manufactured by Coroneo Inc

00817121000532 - Spreader arm - Neonate sternum retractor2024-02-09 Crank-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
00817121000549 - Spreader arm - Neonate sternum retractor2024-02-09 Rack-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor).
00817121000556 - Spreader arm - Infant sternum retractor2024-02-09 Crank-side spreader arm for the infant pediatric retractor, within separable assembly 1100210 (Infant Pediatric Retractor).
00817121000563 - Spreader arm - Infant sternum retractor2024-02-09 Rack-side spreader arm for the infant pediatric retractor, within separable assembly 1100210 (Infant Pediatric Retractor).
00817121000570 - Pinion for pediatric retractors2024-02-09 Pinion for the pediatric retractors, within separable assemblies 1100210 (Infant Pediatric Retractor) and 1100211 (Neonate Pedia
10817121000584 - Pediatric sternum retractor, infant2024-02-09 Pediatric sternum retractor for the infant patient, comprises two spreader arms and one pinion.
10817121000591 - Pediatric sternum retractor, neonate2024-02-09 Sternum retractor for neonate patients. Comprises two spreader arms and a pinion.
10817121000492 - COR-VALV, Artial tissue retractor system2023-07-14 The COR-VALV Atrial retractor system is intended to retract atrial tissue during repair of replacement of the mitral cardiac val

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.