ScopeSafe™Laser Fiber

GUDID B14527750550U131

550 micrometer ScopeSafe laser fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB14527750550U131
NIH Device Record Key64a28630-a844-4bdf-a4bb-3df7f5cf42a0
Commercial Distribution Discontinuation2017-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameScopeSafe™Laser Fiber
Version Model Number27750550U1
Company DUNS024050887
Company NameOPTICAL INTEGRITY INC
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 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

Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com
Phone+1(850)233-5512
Emailcustomercare@opticalintegrity.com

Device Dimensions

Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
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Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer
Device Size Text, specify0
Outer Diameter550 Micrometer

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperature
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB14527750550U10 [Primary]
HIBCCB14527750550U131 [Package]
Contains: B14527750550U10
Package: box [3 Units]
Discontinued: 2017-03-28
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


[B14527750550U131]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-07-28

On-Brand Devices [ScopeSafe™Laser Fiber]

B145P00120300SSR0300 micrometer ScopeSafe laser fiber reusable
B145P00120300SS0300 micrometer ScopeSafe laser fiber
B145P00120272SS0272 micrometer ScopeSafe laser fiber
B145P00120200SS0200 micrometer ScopeSafe laser fiber
B14527750940U131940 micrometer ScopeSafe laser fiber
B14527750550U131550 micrometer ScopeSafe laser fiber
B14527750365U131365 micrometer ScopeSafe laser fiber
B14527750300U131300 micrometer ScopeSafe laser fiber
B14527750272U131272 micrometer ScopeSafe laser fiber
B14527750200U131200 micrometer ScopeSafe laser fiber
B145112110200 micrometer ScopeSafe laser fiber with Sheath
B145109660272 micrometer ScopeSafe laser fiber with 895mm length Sheath
B145109041300 micrometer ScopeSafe laser fiber
B1451085001000 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
B145108490550 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
B145108480365 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
B145108470300 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
B145108460272 micrometer ScopeSafe laser fiber, Convergent compatible, reusable
B145108420300 micrometer ScopeSafe laser fiber, Trimedyne compatible
B145108410272 micrometer ScopeSafe laser fiber, Trimedyne compatible
B145108400200 micrometer ScopeSafe laser fiber, Trimedyne compatible
B145107280272 micrometer ScopeSafe laser fiber with extension sleeve, reusable
B145107190300 micrometer ScopeSafe laser fiber with Sheath
B145106830272 micrometer ScopeSafe laser fiber with Sheath
B145106810200 micrometer ScopeSafe laser fiber with Sheath
B145106450200 micrometer ScopeSafe laser fiber, 4m length
B145106260300 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B145106250272 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B145105910300 micrometer ScopeSafe laser fiber with extension sleeve
B145105600272 micrometer ScopeSafe laser fiber with extension sleeve
B145103880300 micrometer ScopeSafe laser fiber reusable
B145103831940 micrometer ScopeSafe laser fiber
B145103821550 micrometer ScopeSafe laser fiber
B145103811365 micrometer ScopeSafe laser fiber
B145103801272 micrometer ScopeSafe laser fiber
B145103791200 micrometer ScopeSafe laser fiber
B145102360200 micrometer ScopeSafe laser fiber
B145102120300 micrometer ScopeSafe laser fiber
B145102110272 micrometer ScopeSafe laser fiber

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