FDA.reportPublic FDA data

On-X Heart Valve Instruments

Primary DI
00851788001150
Brand
On-X Heart Valve Instruments
Company
ON-X LIFE TECHNOLOGIES, INC.
Model
ONXI2-H
Catalog number
ONXI2-H
Device description
Instrument Handle – all sizes.The instrument handle facilitates holding the valve or the rotator during surgery. The instrument handle is comprised of a grip, a bendable stem and a tip.
Published
2023-08-09
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851788001150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851788001150008517880011508517880011500851788001150

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis sizer handleA hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. 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
1-5123398039onx@onxlti.com

Regulatory Flags#

DUNS number
844782318
Device count
1
DM exempt
true
Premarket exempt
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
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
00851788001570On-X Heart Valve InstrumentsONXI3-27-33SONXI3-27-33S2023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450376171One-Tie®Merit Medical Systems, Inc.DWS2026-06-06
00810220800324Adler Instrument CompanyAdler, Inc.DWS2026-06-02
00846159039931SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039948SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039955SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039962SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039979SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039986SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039993SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040005SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040043SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040050SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040067SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040074SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040081SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040098SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040104SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040111SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040128SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039788SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039795SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039801SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039818SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039825SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039832SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27