Maestro Air 5407-200-000

GUDID 07613327096460

Motor

STRYKER CORPORATION

Surgical power tool system handpiece, rotary, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic Bone/joint surgical power tool motorized handpiece/set, pneumatic

Primary Device ID	07613327096460
NIH Device Record Key	4601e0a1-d0b1-431b-a8e0-1ada566e9df1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Maestro Air
Version Model Number	5407-200-000
Catalog Number	5407-200-000
Company DUNS	196548481
Company Name	STRYKER CORPORATION
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	false
Lot Batch	false
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

Customer Support Contacts

Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com
Phone	+1(800)253-3210
Email	inst.stryker.cs@stryker.com

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327096460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150801

FDA Product Code

HBB	MOTOR, DRILL, PNEUMATIC