Calculase Laser Fiber

GUDID B14527750550U1C31

550 micrometer Calculase Laser Fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB14527750550U1C31
NIH Device Record Key7740f77c-f6c1-49ed-a48a-bea73099907f
Commercial Distribution Discontinuation2017-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCalculase Laser Fiber
Version Model Number27750550U1C
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

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
HIBCCB14527750550U1C0 [Primary]
HIBCCB14527750550U1C31 [Package]
Contains: B14527750550U1C0
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

[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


[B14527750550U1C31]

Ethylene Oxide


Device Entry Metadata

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

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B145110681200 micrometer Calculase Laser Fiber

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