Excalibur 272 micrometer laser fiber

GUDID B1451165150

Excalibur 272 micrometer laser fiber, single use 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
Primary Device IDB1451165150
NIH Device Record Key064a476a-d9a1-499c-a457-bcbfb3eea90e
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcalibur 272 micrometer laser fiber
Version Model NumberSU-200-EX
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 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

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 Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 Micrometer
Outer Diameter272 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB145116170 [Package]
Package: carton [5 Units]
In Commercial Distribution
HIBCCB1451165150 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-21
Device Publish Date2020-07-13

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