MasterPulse Round Tip 365

GUDID B145118010

MasterPulse Round tip laser fiber, 365 micrometer

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB145118010
NIH Device Record Key62bfd68f-ddb4-498a-9718-730d9657c8f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasterPulse Round Tip 365
Version Model NumberSU-365-QRT
Company DUNS024050887
Company NameOPTICAL INTEGRITY INC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM
Phone850-233-5512
EmailCUSTOMERCARE@OPTICALINTEGRITY.COM

Device Dimensions

Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer
Outer Diameter365 Micrometer

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB145118010 [Primary]
HIBCCB145118030 [Package]
Package: carton [5 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-04-07
Device Publish Date2019-06-18

Devices Manufactured by OPTICAL INTEGRITY INC

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00810077630976 - SmartScope2024-04-01 365 MICROMETER LASER FIBER, SINFGLE USE, STERILE
00810077630983 - SmartScope2024-04-01 550 MICROMETER LASER FIBER, SINGLE USE, STERILE
00810077630990 - SmartScope2024-04-01 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE
00810077631348 - SmartScope2024-04-01 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE

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