200 micron Excalibur DC laser fiber 11952

GUDID 00810077631430

200-micron Excalibur DC Laser fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, single-use
Primary Device ID00810077631430
NIH Device Record Key17a0315d-6e37-46f3-8cd6-c932eaba5036
Commercial Distribution StatusIn Commercial Distribution
Brand Name200 micron Excalibur DC laser fiber
Version Model Number11952
Catalog Number11952
Company DUNS024050887
Company NameOPTICAL INTEGRITY INC
Device Count1
DM Exemptfalse
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 Datefalse
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
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com
Phone850-233-5512
Emailcontact@opticalintegrity.com

Device Dimensions

Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 Micrometer
Outer Diameter200 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810077631430 [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 Date2025-03-10
Device Publish Date2025-02-28

Devices Manufactured by OPTICAL INTEGRITY INC

00810077631430 - 200 micron Excalibur DC laser fiber2025-03-10200-micron Excalibur DC Laser fiber
00810077631430 - 200 micron Excalibur DC laser fiber2025-03-10 200-micron Excalibur DC Laser fiber
00810077631393 - 300 micron laser fiber (KTP) with ScopeGuardian sheath2024-10-02 300 micron laser fiber (KTP) with ScopeGuardian sheath, single use, sterile
00810077631362 - 300 micron laser fiber (KTP)2024-09-16 300-micron laser fiber, single use disposable (KTP)
00810077631355 - 300 micron laser fiber (KTP)2024-08-19 300 micron laser fiber, single use disposable (KTP)
00810077630969 - SmartScope2024-04-01 272 MICROMETER LASER FIBER, SINGLE USE, STERILE
00810077630976 - SmartScope2024-04-01 365 MICROMETER LASER FIBER, SINFGLE USE, STERILE
00810077630983 - SmartScope2024-04-01 550 MICROMETER LASER FIBER, SINGLE USE, STERILE
00810077630990 - SmartScope2024-04-01 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE

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