FDA.reportPublic FDA data

HM-550

Primary DI
00851272007125
Brand
HM-550
Company
INTERNATIONAL MEDICAL LASERS, INC.
Model
HM-550
Device description
Surgical Laser Fiber 550/608/780, silicone, blue tefzel, NA 0.22, damage resistant SMA905, single use, blue extension sleeves with logo, EO sterile, Flat Tip, IML label
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00851272007125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851272007125008512720071258512720071250851272007125

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. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit286 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078534357
Device count
1
HCT/P
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851272007002HM-1000HM-10002016-08-24
00851272007019HM-200A-BTHM-200A-BT2016-08-24
00851272007026HM-200A-DTHM-200A-DT2016-08-24
00851272007033HM-272A-DTHM-272A-DT2016-08-24
00851272007040HM-272A-BTHM-272A-BT2016-08-24
00851272007057HM-272A-L-DT-FBHM-272A-L-DT-FB2016-08-24
00851272007064HM-272A-L-FBHM-272A-L-FB2016-08-24
00851272007071HM-365AHM-365A2016-08-24
00851272007088HM-365A-BTHM-365A-BT2016-08-24
00851272007095HMR-365AHM-365A-DT2016-08-24
00851272007101HM-365A-L-DT-FBHM-365A-L-DT-FB2016-08-24
00851272007118HM-365A-L-FBHM-365A-L-FB2016-08-24
00851272007132HMR-1000HMR-10002016-08-24
00851272007149HMR-200AHMR-200A2016-08-24
00851272007156HMR-272AHMR-272A2016-08-24
00851272007163HMR-365AHMR-365A2016-08-24
00851272007170HMR-365LHMR-365L2016-08-24
00851272007187HMR-550HMR-5502016-08-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
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08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
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08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
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