FDA.reportPublic FDA data

HMR-550

Primary DI
00851272007187
Brand
HMR-550
Company
INTERNATIONAL MEDICAL LASERS, INC.
Model
HMR-550
Device description
Reusable Surgical Laser Fiber 550/608/780, silicone, blue tefzel, NA 0.22, damage resistant SMA905, reusable, 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

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
00851272007187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851272007187008512720071878512720071870851272007187

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
"[""Radiation Sterilization"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide

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
Sterilization required before use
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
00851272007125HM-550HM-5502016-08-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16