Navbit Sprint_Supine

GUDID 09369998068180

Cup Alignment Technology for Hip Replacement

NAVBIT PTY LTD

Orthopaedic stereotactic surgery system

• Primary Device ID: 09369998068180
• NIH Device Record Key: 0502ffa4-2a3b-41df-96b0-581e29206731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navbit Sprint_Supine
• Version Model Number: HBS-00-001
• Company DUNS: 744162019
• Company Name: NAVBIT PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com
• Phone: +61433482325
• Email: dave.thomson@navbit.com

Device Dimensions

• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Transport Temp -29-60 Deg. Celsius and 15-90%RH

Device Identifiers

Device Issuing Agency	Device ID
GS1	09369998068180 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-05
• Device Publish Date: 2021-04-27

Devices Manufactured by NAVBIT PTY LTD

• 09369998068180 - Navbit Sprint_Supine: 2021-05-05Cup Alignment Technology for Hip Replacement
• 09369998068180 - Navbit Sprint_Supine: 2021-05-05 Cup Alignment Technology for Hip Replacement
• 09369998142903 - Navbit Sprint_Lateral: 2021-05-05 Cup Alignment Technology for Hip Replacement