Zimmer Biomet Atlas Pro-Driver Battery, Single Use

GUDID 00856482008498

PRO-DEX, INC.

Disposable battery pack

• Primary Device ID: 00856482008498
• NIH Device Record Key: 800aee13-4b3d-41c5-a5ae-0251f16f0ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer Biomet Atlas Pro-Driver Battery, Single Use
• Version Model Number: APD-BP-001S-4
• Company DUNS: 849370358
• Company Name: PRO-DEX, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 58 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 59 KiloPascal and 97 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856482008498 [Primary]

FDA Product Code

• GEY: Motor, Surgical Instrument, Ac-Powered

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: 2023-11-03
• Device Publish Date: 2023-10-26

Devices Manufactured by PRO-DEX, INC.

• 00856482008498 - Zimmer Biomet Atlas Pro-Driver Battery, Single Use: 2023-11-03
• 00856482008498 - Zimmer Biomet Atlas Pro-Driver Battery, Single Use: 2023-11-03
• 00856482008474 - Zimmer Biomet 90D Atlas Blade: 2023-06-21
• 00856482008184 - Zimmer Biomet Atlas Pro Driver Sterilization Container: 2023-06-19
• 00856482008436 - Zimmer Biomet Atlas Pro Driver: 2023-06-19
• 00856482008443 - Zimmer Biomet 90D Collet: 2023-06-19
• 00856482008481 - Zimmer Biomet Straight Collet: 2023-06-19
• 00856482008467 - KLS E-Coupling Adapter: 2023-05-31
• 00856482008252 - Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER): 2022-04-11