On-X Heart Valve Instruments ONXI2-LP

GUDID 00851788001167

The leaflet probe (all sizes) is a flexible rod with tapered ends. The leaflet probe may be used to gently move the leaflets to verify that they open and close freely.

ON-X LIFE TECHNOLOGIES, INC.

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• Primary Device ID: 00851788001167
• NIH Device Record Key: e962d785-6230-456a-a021-8ccd86ea8d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On-X Heart Valve Instruments
• Version Model Number: ONXI2-LP
• Catalog Number: ONXI2-LP
• Company DUNS: 844782318
• Company Name: ON-X LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com
• Phone: 15123398039
• Email: onx@onxlti.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *stored in a clean, cool and dry environment.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851788001167 [Primary]

FDA Product Code

• LXN: Probe, Test, Heart-Valve

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

[00851788001167]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

On-Brand Devices [On-X Heart Valve Instruments]

• 00851788001792: Rotator For mitral valve sizes 25-33. The valve rotator is used for reorienting an in-situ valv
• 00851788001747: The instrument tray (Gold) is optional and may be used for storage and transportation of On-X®
• 00851788001730: Instrument Kit Aortic and Mitral (Gold). The instrument kit contains the sizers and rotators for
• 00851788001587: Aortic Sizers for valve size 25 (Gold). The sizers are used to gauge the resulting tissue annulu
• 00851788001570: Mitral Sizes for valve sizes 27/29 and 31/33 (Gold). The sizers are used to gauge the resulting
• 00851788001563: Mitral Sizers for valve sizes 23 ,25 and 25/33(Gold). The sizers are used to gauge the resulting
• 00851788001556: Aortic Sizers for valve size 27/29mm (Gold).The sizers are used to gauge the resulting tissue an
• 00851788001198: Aortic Sizers for valve size 23mm (Gold).The sizers are used to gauge the resulting tissue annul
• 00851788001181: Aortic Sizers for valve size 21 (Gold).The sizers are used to gauge the resulting tissue annulus
• 00851788001174: The instrument tray (Grey) is optional and may be used for storage and transportation of On-X®
• 00851788001167: The leaflet probe (all sizes) is a flexible rod with tapered ends. The leaflet probe may be used
• 00851788001150: Instrument Handle – all sizes. The instrument handle facilitates holding the valve or the rota
• 00851788001143: Aortic Sizers for valve size 27/29 (Grey). The sizers are used to gauge the resulting tissue ann
• 00851788001136: Mitral Sizers for valve sizes 23, 25 and 25/33 (Grey). The sizers are used to gauge the resultin
• 00851788001129: Mitral Sizer for valve sizes 27/29 and 31/33 (Grey). The sizers are used to gauge the resulting
• 00851788001112: Aortic Sizers for valve size 25(grey). The sizers are used to gauge the resulting tissue annulus
• 00851788001105: Aortic Sizers for valve size 23(grey). The sizers are used to gauge the resulting tissue annulus
• 00851788001099: Aortic Sizers for valve size 21(grey).The sizers are used to gauge the resulting tissue annulus
• 00851788001082: Aortic SIzers for valve size 19 (grey). The sizers are used to gauge the resulting tissue annulu
• 00851788001068: Aortic Sizers for valve size 19 (Gold).The sizers are used to gauge the resulting tissue annulus
• 00851788001051: Rotator For valve sizes 25. The valve rotator is used for reorienting an in-situ valve and may b
• 00851788001044: Rotator For valve size 23. The valve rotator is used for reorienting an in-situ valve and may be
• 00851788001037: Rotator For valve size 21. The valve rotator is used for reorienting an in-situ valve and may be
• 00851788001020: Rotator for heart valve size 19. The valve rotator is used for reorienting an in-situ valve and
• 00851788001006: Instrument Kit Aortic and Mitral (Grey).The instrument kit contains the sizers and a rotators fo