MasterPulse laser fiber 550 Round tip

GUDID B145118080

MasterPulse laser fiber 550 micrometers, Round Tip

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, reusable
Primary Device IDB145118080
NIH Device Record Key21b00818-cf8d-4494-90ff-040cc03fa1b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasterPulse laser fiber 550 Round tip
Version Model NumberSU-550-QRT
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

Device Dimensions

Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 Micrometer
Outer Diameter550 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB145118050 [Primary]
HIBCCB145118080 [Package]
Contains: B145118050
Package: carton [5 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-04-07
Device Publish Date2019-06-18

Devices Manufactured by OPTICAL INTEGRITY INC

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
00810077631348 - SmartScope2024-04-01 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE

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