ScopeSafe™Laser Fiber reusable

GUDID B145102400

272 micrometer ScopeSafe laser fiber reusable

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB145102400
NIH Device Record Keyf8c57450-e560-43e2-8d73-141f1c3c8b60
Commercial Distribution StatusIn Commercial Distribution
Brand NameScopeSafe™Laser Fiber reusable
Version Model Number10240
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

Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 Micrometer
Device Size Text, specify0
Outer Diameter272 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
HIBCCB145102400 [Primary]
HIBCCB145102401 [Package]
Package: box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


[B145102400]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-08-03

On-Brand Devices [ScopeSafe™Laser Fiber reusable]

B145P00120272SSR0272 micrometer ScopeSafe laser fiber reusable
B145102400272 micrometer ScopeSafe laser fiber reusable

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