FDA.reportPublic FDA data

On-X Heart Valve Instruments

Primary DI
00851788001006
Brand
On-X Heart Valve Instruments
Company
ON-X LIFE TECHNOLOGIES, INC.
Model
ONXI2-CK
Catalog number
ONXI2-CK
Device description
Instrument Kit Aortic and Mitral (Grey).The instrument kit contains the sizers and a rotators for each size of the On-X® Prosthetic Heart Valve and On-X® Ascending Aortic Prosthesis. A universal instrument handle and leaflet probe are also included. The instruments are reusable.
Published
2023-08-08
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
OFACardiovascular Surgical Instruments Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851788001006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851788001006008517880010068517880010060851788001006

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve repair/prosthesis implantation kitA collection of dedicated instruments intended to be used during heart valve repair and/or implantation of a heart valve prosthesis during an open surgical procedure. The kit typically includes two or more of the following: annulus sizers, rulers (e.g., aortic valve cusp ruler), a handle, repositioning tool, and a valve tester, which may be arranged in a sterilizable instrument tray. Implantable devices (e.g., heart valve prosthesis) are not included in the kit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00stored in a clean, cool and dry environment.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
15123398039onx@onxlti.com

Regulatory Flags#

DUNS number
844782318
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851788001495Chord-X Chordal SizerCXCSCXCS2023-10-12
00851788001020On-X Heart Valve InstrumentsONXI2-19RONXI2-19R2023-08-09
00851788001037On-X Heart Valve InstrumentsONXI2-21RONXI2-21R2023-08-09
00851788001044On-X Heart Valve InstrumentsONXI2-23RONXI2-23R2023-08-09
00851788001051On-X Heart Valve InstrumentsONXI2-25RONXI2-25R2023-08-09
00851788001068On-X Heart Valve InstrumentsONXI3-19SONXI3-19S2023-08-09
00851788001082On-X Heart Valve InstrumentsONXI2-19SONXI2-19S2023-08-09
00851788001099On-X Heart Valve InstrumentsONXI2-21SONXI2-21S2023-08-09
00851788001105On-X Heart Valve InstrumentsONXI2-23SONXI2-23S2023-08-09
00851788001112On-X Heart Valve InstrumentsONXI2-25SONXI2-25S2023-08-09
00851788001129On-X Heart Valve InstrumentsONXI2-27-33SONXI2-27-33S2023-08-09
00851788001136On-X Heart Valve InstrumentsONXI2-23-25SONXI2-23-25S2023-08-09
00851788001143On-X Heart Valve InstrumentsONXI2-27-29SONXI2-27-29S2023-08-09
00851788001150On-X Heart Valve InstrumentsONXI2-HONXI2-H2023-08-09
00851788001167On-X Heart Valve InstrumentsONXI2-LPONXI2-LP2023-08-09
00851788001174On-X Heart Valve InstrumentsONXI2-CTONXI2-CT2023-08-09
00851788001181On-X Heart Valve InstrumentsONXI3-21SONXI3-21S2023-08-09
00851788001198On-X Heart Valve InstrumentsONXI3-23SONXI3-23S2023-08-09
00851788001556On-X Heart Valve InstrumentsONXI3-27-29SONXI3-27-29S2023-08-09
00851788001563On-X Heart Valve InstrumentsONXI3-23-25SONXI3-23-25S2023-08-09

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