FDA.reportPublic FDA data

MegaBeam® Fiber Optic Delivery System with Additio

Primary DI
04049089300607
Brand
MegaBeam® Fiber Optic Delivery System with Additio
Company
Ceram Optec SIA
Model
MegaBeam® Single Use Handpiece 400um, 15 deg, noID
Catalog number
AP-400-15
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
04049089200600PackageGS11In Commercial Distribution
04049089300607PackageGS15In Commercial Distribution
04049089100603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049089200600040490892006004049089200600
04049089300607040490893006074049089300607
04049089100603040490891006034049089100603

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-use, sterileA sterile, 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
506069240
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04049089100412MegaBeam® Reusable Fiber Optic Delivery SystemMegaBeam® Reusable Bare Fiber 550um, Flat Tip, noI1011552017-01-31
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

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