FDA.reportPublic FDA data

MegaBeam® Endo-ENT Probe

Primary DI
04049089300317
Brand
MegaBeam® Endo-ENT Probe
Company
Ceram Optec SIA
Model
MegaBeam® Endo-ENT Probe, 24Ga, COH-H, noID
Catalog number
ENT-24-COH-H
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
04049089200310PackageGS15In Commercial Distribution
04049089300317PackageGS12In Commercial Distribution
04049089100313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049089200310040490892003104049089200310
04049089300317040490893003174049089300317
04049089100313040490891003134049089100313

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
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
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14