200µm ScopeSafe Laser Fiber 10366

GUDID 00810077630082

200µm ScopeSafe Laser Fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use
Primary Device ID00810077630082
NIH Device Record Key90b90c8e-1e9d-40e0-86af-a6cedc9e769a
Commercial Distribution StatusIn Commercial Distribution
Brand Name200µm ScopeSafe Laser Fiber
Version Model NumberKS-0200S-FT-000-BLU-1
Catalog Number10366
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
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@opticalintegrity.com
Phone850-233-5512
Emailpurchasing@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
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

Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810077630082 [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 Date2021-05-19
Device Publish Date2021-05-11

Devices Manufactured by OPTICAL INTEGRITY INC

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
00810077631348 - SmartScope2024-04-01 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE
00810077635711 - 200 TRUE ForTec Thulium TFL Laser Fiber2021-07-14 200 TRUE ForTec Thulium TFL Laser Fiber
00810077635728 - 272 ForTec Thulium TFL Laser Fiber2021-07-14 272 ForTec Thulium TFL Laser Fiber
00810077635735 - 365 ForTec Thulium TFL Laser Fiber2021-07-14 365 ForTec Thulium TFL Laser Fiber

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.