Zimmer Biomet Atlas Pro Driver

GUDID 00856482008436

PRO-DEX, INC.

Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Primary Device ID	00856482008436
NIH Device Record Key	cb5d31bd-5b9e-4df0-8b2f-12a5cd24f770
Commercial Distribution Status	In Commercial Distribution
Brand Name	Zimmer Biomet Atlas Pro Driver
Version Model Number	APD-1000-4
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	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
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

Operating and Storage Conditions

Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -16 Degrees Celsius and 58 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 59 KiloPascal and 97 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856482008436 [Primary]

FDA Product Code

GEY	Motor, Surgical Instrument, Ac-Powered