OSYFIBRE

GUDID 03760227850150

STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE

LSO MEDICAL

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID03760227850150
NIH Device Record Key506a3d50-d250-43c4-89f3-befd509dde26
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSYFIBRE
Version Model NumberPH-EO-980-25-600-3
Company DUNS263931746
Company NameLSO MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com
Phone+33320679000
Emailcontact@lsomedical.com

Device Dimensions

Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter
Outer Diameter1040 Micrometer
Lumen/Inner Diameter600 Micrometer
Length3 Meter

Operating and Storage Conditions

Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760227850150 [Primary]
GS103760227850167 [Package]
Package: Cardboard [10 Units]
In Commercial Distribution
GS103760227850228 [Package]
Package: Cardboard [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number5
Public Version Date2020-11-06
Device Publish Date2016-10-12

Devices Manufactured by LSO MEDICAL

03760227850150 - OSYFIBRE2020-11-06STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE
03760227850150 - OSYFIBRE2020-11-06 STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE
03760227850181 - OSYHAND2020-11-06 STERILE MEDICAL HANDPIECE FOR SINGLE USE
03760227850204 - SMOOTHKIT+2020-11-06 STERILE MEDICAL HANDPIECE FOR SINGLE USE
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.