Hyper LT 5450-811-000

GUDID 07613327291957

Hard Tissue Curette Handpiece without Tip, 25 kHz

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
Primary Device ID07613327291957
NIH Device Record Key12cf8193-a747-4615-9916-71208e55b8ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyper LT
Version Model Number5450811000
Catalog Number5450-811-000
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

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327291957 [Primary]

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


[07613327291957]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-06
Device Publish Date2018-09-24

On-Brand Devices [Hyper LT]

07613327291957Hard Tissue Curette Handpiece without Tip, 25 kHz
07613327289893Angled Hard Tissue Curette Handpiece without Tip, 25 kHz

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