272 Excalibur Laser Fiber 11615

GUDID 00810077632024

272 Excalibur Laser Fiber

OPTICAL INTEGRITY INC

General/multiple surgical laser system beam guide, single-use
Primary Device ID00810077632024
NIH Device Record Key7c6de6e7-5831-4c3e-a743-5fb876556df9
Commercial Distribution StatusIn Commercial Distribution
Brand Name272 Excalibur Laser Fiber
Version Model NumberFT-0272S-FT-STO-FOR-1
Catalog Number11615
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

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

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
GS100810077630570 [Primary]
GS100810077632024 [Package]
Contains: 00810077630570
Package: Carton [1 Units]
In Commercial Distribution
GS100810077636565 [Package]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-19
Device Publish Date2021-05-11

On-Brand Devices [272 Excalibur Laser Fiber]

00810077632024272 Excalibur Laser Fiber
00810077635636272 Excalibur Laser Fiber

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