FDA.reportPublic FDA data

On-X Heart Valve Instruments

Primary DI
00851788001037
Brand
On-X Heart Valve Instruments
Company
ON-X LIFE TECHNOLOGIES, INC.
Model
ONXI2-21R
Catalog number
ONXI2-21R
Device description
Rotator For valve size 21. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility.
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
00851788001037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851788001037008517880010378517880010370851788001037

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis repositioning toolA hand-held manual surgical instrument intended to be used to realign or reposition a heart valve prosthesis after initial insertion and positioning with a heart valve prosthesis holder. The device may be a one-piece instrument or attached to a separate handle, and is available in a range of configurations for the aortic, mitral, or tricuspid heart valve. It is typically made of plastic materials. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
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
00851788001570On-X Heart Valve InstrumentsONXI3-27-33SONXI3-27-33S2023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18
00190776411107MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411473MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411497MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411510MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31