Maestro Air 5407-200-000

GUDID 07613327096460

Motor

STRYKER CORPORATION

Surgical power tool system handpiece, rotary, pneumatic
Primary Device ID07613327096460
NIH Device Record Key4601e0a1-d0b1-431b-a8e0-1ada566e9df1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaestro Air
Version Model Number5407-200-000
Catalog Number5407-200-000
Company DUNS196548481
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327096460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBBMOTOR, DRILL, PNEUMATIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


[07613327096460]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-20
Device Publish Date2016-09-23

On-Brand Devices [Maestro Air]

07613327128727Motor with Handswitch
07613327096460Motor

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