VERASENSE for Zimmer Biomet Persona ZBH-PSNCRCD39-L

GUDID 00816818021478

ORTHOSENSOR INC

Arthroplasty force sensor

• Primary Device ID: 00816818021478
• NIH Device Record Key: cd8c2c43-55a8-46bb-8308-d2603c9e2a42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERASENSE for Zimmer Biomet Persona
• Version Model Number: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef
• Catalog Number: ZBH-PSNCRCD39-L
• Company DUNS: 005788130
• Company Name: ORTHOSENSOR INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 36 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 47 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816818021478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180459

FDA Product Code

• ONN: Intraoperative Orthopedic Joint Assessment Aid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2020-11-18

On-Brand Devices [VERASENSE for Zimmer Biomet Persona]

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• 00816818021515: VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Le
• 00816818021508: VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Ri
• 00816818021492: VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Le
• 00816818021485: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Rig
• 00816818021478: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef