300 ScopeSafe Laser Fiber 10212

GUDID 00810077633021

300 ScopeSafe Laser Fiber, Single Use

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
Primary Device ID00810077633021
NIH Device Record Key40671aa0-f90a-41f6-a49f-26010b22e322
Commercial Distribution StatusIn Commercial Distribution
Brand Name300 ScopeSafe Laser Fiber
Version Model NumberOI-0300S-FT-000-BIG-1
Catalog Number10212
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

Device Dimensions

Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 Micrometer
Outer Diameter300 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810077630020 [Primary]
GS100810077633021 [Package]
Contains: 00810077630020
Package: Carton [3 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 Date2021-04-21
Device Publish Date2021-04-13

On-Brand Devices [300 ScopeSafe Laser Fiber]

00810077633021300 ScopeSafe Laser Fiber, Single Use
00810077630181300 ScopeSafe Laser Fiber
00810077633274300 ScopeSafe Laser Fiber

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