FDA.reportPublic FDA data

MegaBeam® Reusable Fiber Optic Delivery System

Primary DI
04049089100412
Brand
MegaBeam® Reusable Fiber Optic Delivery System
Company
Ceram Optec SIA
Model
MegaBeam® Reusable Bare Fiber 550um, Flat Tip, noI
Catalog number
101155
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049089200419PackageGS15In Commercial Distribution
04049089300416PackageGS12In Commercial Distribution
04049089100412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049089200419040490892004194049089200419
04049089300416040490893004164049089300416
04049089100412040490891004124049089100412

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
506069240
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049089100306MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, COH-G, noIDENT-24-COH-G2017-03-07
04049089100313MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, COH-H, noIDENT-24-COH-H2017-03-07
04049089100320MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, COH-S, noIDENT-24-COH-S2017-03-07
04049089100337MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, HGM-G, noIDENT-24-HGM-G2017-03-07
04049089100344MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, HGM-H, noIDENT-24-HGM-H2017-03-07
04049089100351MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, HGM-S, noIDENT-24-HGM-S2017-03-07
04049089100368MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, SMA-G, noIDENT-24-SMA-G2017-03-07
04049089100375MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, SMA-H, noIDENT-24-SMA-H2017-03-07
04049089100382MegaBeam® Endo-ENT ProbeMegaBeam® Endo-ENT Probe, 24Ga, SMA-S, noIDENT-24-SMA-S2017-03-07
04049089100399MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 230um, Flat Tip, noI1011352017-01-31
04049089100405MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 365um, Flat Tip, noI1011452017-01-31
04049089100429MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 1000um, Flat Tip, no1011652017-01-31
04049089100474MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 600um, Flat Tip PF1010152017-03-07
04049089100481MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 1000um, Flat Tip F1010352017-03-07
04049089100498MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 600um, Flat Tip FT1010402017-03-07
04049089100504MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 400um, Flat Tip, I1010452017-03-07
04049089100511MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 1000um, Flat Tip, 1010902017-03-07
04049089100528MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 600um, Flat Tip, I1010952017-03-07
04049089100535MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 230um, Flat Tip, I1011302017-03-07
04049089100542MegaBeam® Fiber Optic Delivery System with Additional Tips and HandpieceMegaBeam® Single Use Bare Fiber 365um, Flat Tip DO1011402017-03-07

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