5450840000

GUDID 07613327291933

Straight Universal Handpiece

STRYER MEDTEC K.K.

Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable Soft-tissue ultrasonic surgical system handpiece, reusable
Primary Device ID07613327291933
NIH Device Record Key9b278d02-29a5-4eee-a125-953063eed0aa
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5450840000
Catalog Number5450840000
Company DUNS690682147
Company NameSTRYER MEDTEC K.K.
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
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327291933 [Primary]

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


[07613327291933]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

Devices Manufactured by STRYER MEDTEC K.K.

07613327291827 - NA2020-01-06 Hyper Small Angled Handpiece without Tip, 25 kHz
07613327291957 - Hyper LT2020-01-06 Hard Tissue Curette Handpiece without Tip, 25 kHz
07613327289893 - Hyper LT2018-10-25 Angled Hard Tissue Curette Handpiece without Tip, 25 kHz
07613327291483 - NA2018-10-25 Torque Wrench, 1.96 Nm - 7 mm
07613327291490 - NA2018-10-25 Wrench, 10 mm
07613327291513 - NA2018-10-25 Step Torque Wrench, 7 mm
07613327291520 - NA2018-10-25 Step Torque Wrench, Offset, 7 mm
07613327291537 - NA2018-10-25 Cleaning Wire

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.