Smart Scope 1000 micrometer reusable laser fiber 11780

GUDID B14511782

Smart Scope 1000 micrometer reusable laser fiber, packaged sterile

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable
Primary Device IDB14511782
NIH Device Record Key5bb28376-1b5d-4a07-8ff0-546a5b1cec91
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Scope 1000 micrometer reusable laser fiber
Version Model NumberSU-1000-DO
Catalog Number11780
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 Usefalse
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
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 Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer
Outer Diameter1000 Micrometer

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB145117800 [Primary]
HIBCCB14511782 [Package]
Contains: B145117800
Package: CARTON [5 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


[B14511782]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-22
Device Publish Date2020-07-14

Devices Manufactured by OPTICAL INTEGRITY INC

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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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00810077635728 - 272 ForTec Thulium TFL Laser Fiber2021-07-14 272 ForTec Thulium TFL Laser Fiber
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