N/A 7400-015-043

GUDID 07613327503883

Micro Drill 5:1 Reducer

STRYKER CORPORATION

Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic Drilling power tool attachment, basic
Primary Device ID07613327503883
NIH Device Record Key46b863ca-8521-4d6b-a88a-a7544dc445bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number7400015043
Catalog Number7400-015-043
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 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
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]
GS107613327503883 [Primary]

FDA Product Code

DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED
DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


[07613327503883]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [N/A]

076133274022782.5mm Extended Match Head
076133274022542.5mm Extended Precision Match Head
3761332738145112cm Elite Irrigation Sleeve
3761332738144416cm MIS Irrigation Sleeve
376133273814377cm Elite Irrigation Sleeve
3761332738142013cm MIS Irrigation Sleeve
07613327363616Hybrid Insert Tray
07613327311891Bipolar Generator Coag-Only Single Foot Pedal
37613327304269Bipolar Cord Set, Disposable
37613327304252Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
37613327304245Integrated Tubing and Bipolar Cord Set, Disposable
37613327304221Bipolar Cord Set, Disposable, Unitized Plug
37613327304207Bipolar Irrigator Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
37613327304191Bipolar Irrigator Integrated Tubing and Bipolar Cord Set, Disposable
07613327303902Bipolar Generator Cart
07613327303896Bipolar Irrigator Power Cord
07613327303889Bipolar Generator
07613327303872Bipolar Generator Cut/Coag Dual Foot Pedal
07613327303865Bipolar Irrigator
07613327303858Bipolar Foot Pedal Adapter Cable
07613327303841Bipolar Generator/Irrigator Interconnect Cable
07613327294996Precision Acorn
07613327294989Carbide Match Head
07613327294972Carbide Round
07613327294965Diamond Match Head
07613327294958Round Diamond, Extended
07613327294941Round
07613327294934Round Diamond
07613327294927Carbide Round, Extended
07613327294910Tapered Router
07613327294903Round Diamond, Extended
07613327294897Round, Extended
07613327294880Spiral Router
07613327294873Diamond Match Head
07613327294866Round
07613327294859Round
07613327294842Carbide Round
07613327294835Carbide Round, Extended
07613327294828Round, Extended
07613327294811Match Head
07613327294804Round
07613327294798Precision Acorn
07613327294781Round Diamond
07613327294774Precision Acorn
07613327294767Carbide Round
07613327294750Round, Extended
07613327294743Carbide Round
07613327294736Carbide Round
07613327294729Match Head
07613327294712Round Diamond, Extended

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.