FDA.reportPublic FDA data

OSYFIBRE

Primary DI
03760227850150
Brand
OSYFIBRE
Company
LSO MEDICAL
Model
PH-EO-980-25-600-3
Device description
STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080731000PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECEOsyris2008-07-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760227850167PackageGS110In Commercial Distribution
03760227850228PackageGS15In Commercial Distribution
03760227850150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760227850167037602278501673760227850167
03760227850228037602278502283760227850228
03760227850150037602278501503760227850150

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Meter
Lumen/Inner Diameter600Micrometer
Outer Diameter1040Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33320679000contact@lsomedical.com

Regulatory Flags#

DUNS number
263931746
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760227850174OSYHANDOSYHAND2016-10-12
03760227850198SMOOTHKIT+SK+-EO-980-25-600-32016-10-12
03760227850181OSYHANDOSYHAND2016-10-12
03760227850204SMOOTHKIT+SK+-EO-980-25-600-32016-10-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14