Optical Integrity Laser Fiber

GUDID B145P00120550R0

550 micrometer laser fiber reusable

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB145P00120550R0
NIH Device Record Keyecd1c149-cf4a-4413-9671-b01a85cd72b6
Commercial Distribution Discontinuation2017-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOptical Integrity Laser Fiber
Version Model NumberP00120550R
Company DUNS024050887
Company NameOPTICAL INTEGRITY INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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

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

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

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
HIBCCB145P00120550R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

Ethylene Oxide


[B145P00120550R0]

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 [Optical Integrity Laser Fiber]

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B145P0012100001000 micrometer laser fiber
B145P00120550R0550 micrometer laser fiber reusable
B145P001205500550 micrometer laser fiber
B145P00120365R0365 micrometer laser fiber reusable
B145P001203650365 micrometer laser fiber
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B145114141550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B145114121365 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B145114101272 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B1451121311000 micrometer laser fiber with SMA extension sleeve
B145109260550 micrometer laser fiber, 4m length
B1451084501000 micrometer laser fiber, Trimedyne compatible
B145108440550 micrometer laser fiber, Trimedyne compatible
B145108430365 micrometer laser fiber, Trimedyne compatible
B145107410550 micrometer laser fiber with extension sleeve, reusable
B145107390365 micrometer laser fiber with extension sleeve, reusable
B145106780600 micrometer reduced buffer with SMA 905 Connector, reusable
B145106740365 micrometer Laser fiber, 4m length
B145106620400 micrometer Laser fiber
B145106280550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B145106270365 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
B145105920550 micrometer laser fiber with extension sleeve
B145105480365 micrometer laser fiber with extension sleeve
B145104870600 micrometer laser fiber without boot
B145104430600 micrometer laser fiber with SMA 905 Connector
B1451039101000 micrometer laser fiber reusable
B145103900550 micrometer laser fiber reusable
B145103890365 micrometer laser fiber reusable
B1451023901000 micrometer laser fiber
B145102380550 micrometer laser fiber
B145102370365 micrometer laser fiber
B145101530600 micrometer laser fiber without sleeve
B145101510600 micrometer laser fiber without sleeve reusable

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