Lazurite Holdings LLC ArthroFree Battery Set

GUDID 10860001744221

Lazurite Holdings LLC

Video camera surgical microscope system
Primary Device ID10860001744221
NIH Device Record Key9c4581e4-ae7b-40b5-9930-c527028d8c99
Commercial Distribution StatusIn Commercial Distribution
Brand NameLazurite Holdings LLC ArthroFree Battery Set
Version Model NumberAF0015-101-10
Company DUNS088448366
Company NameLazurite Holdings LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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(833)214-2324
Emaildanielle@lazurite.co
Phone+1(833)214-2324
Emaildanielle@lazurite.co
Phone+1(833)214-2324
Emaildanielle@lazurite.co
Phone+1(833)214-2324
Emaildanielle@lazurite.co
Phone+1(833)214-2324
Emaildanielle@lazurite.co
Phone+1(833)214-2324
Emaildanielle@lazurite.co
Phone+1(833)214-2324
Emaildanielle@lazurite.co

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal
Handling Environment Atmospheric PressureBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS110860001744221 [Primary]

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10860001744221]

Hydrogen Peroxide


[10860001744221]

Hydrogen Peroxide


[10860001744221]

Hydrogen Peroxide


[10860001744221]

Hydrogen Peroxide


[10860001744221]

Hydrogen Peroxide


[10860001744221]

Hydrogen Peroxide


[10860001744221]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-05

Devices Manufactured by Lazurite Holdings LLC

00850045863005 - Lazurite Holdings LLC ArthroFree Sterilization Tray Kit2022-09-22
00860001744279 - Lazurite Holdings LLC ArthroFree Receiver Kit2022-09-22
00860001744286 - Lazurite Holdings LLC ArthroFree Battery Charger Kit2022-09-22
00860001744293 - Lazurite Holdings LLC ArthroFree Sterilization Tray Kit2022-09-22
00860001744200 - Lazurite Holdings LLC Wireless Camera Head2022-06-13
00860001744217 - Lazurite Holdings LLC Sterilization Tray2022-06-13
00860001744224 - Lazurite Holdings LLC Battery2022-06-13
00860001744231 - Lazurite Holdings LLC Battery Charger2022-06-13

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