FDA.reportPublic FDA data

Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight

Primary DI
M47320495HP1
Brand
Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight
Company
TRIMEDYNE, INC.
Model
20495-HP
Catalog number
20495-HP
Device description
Tip, Switchable, 0 degree, SJ-90
Published
2018-07-11
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

Contact Domains#

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
M47320495HP1PackageHIBCC5In Commercial Distribution
M47320495HP0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8007335273customerservice@trimedyne.com

Regulatory Flags#

DUNS number
057007239
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
M4731210VHP0Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System1210-VHP1210-VHP2018-07-11
M47321200Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System212021202023-06-14
M47320462HP0Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle20462-HP20462-HP2018-07-11
M47320474HP0Trimedyne® OmniTip™ Switchable Tip - Straight20474-HP20474-HP2018-07-11
M47320475HP0Trimedyne® OmniTip™ Switchable Tip - 20°20475-HP20475-HP2018-07-11
M47320475MHP0Trimedyne® Reposable OmniTip™ Switchable Tip - 20°20475M-HP20475M-HP2018-07-11
M47320476HP0Trimedyne® OmniTip™ Switchable Tip - 30°20476-HP20476-HP2018-07-11
M47320476MHP0Trimedyne® Reposable OmniTip™ Switchable Tip - 30°20476M-HP20476M-HP2018-07-11
M47320478HP0Trimedyne® OmniTip™ Switchable Tip - 60°20478-HP20478-HP2018-07-11
M47320479HP0Trimedyne® OmniTip™ Switchable Tip - Side Firing20479-HP20479-HP2018-07-11
M47320489HP0Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable Tip20489-HP20489-HP2018-07-11
M47320495HP0Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight20495-HP20495-HP2018-07-11
M47320496HP0Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Side Firing20496-HP20496-HP2018-07-11
M47320497HP0Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight20497-HP20497-HP2018-07-11
M473S10000Trimedyne® FlexMax® 1000 µm Single Use Holmium FiberS1000S10002018-07-11
M473S1000SMA0Trimedyne® FlexMax® 1000 µm Single Use Fiber (SMA Connector)S1000SMAS1000SMA2018-07-11
M473S2000Trimedyne® FlexMax® 200 µm Single Use Holmium Bare FiberS200S2002018-07-11
M473S200SMA0Trimedyne® FlexMax® 200 µm Single Use Holmium Fiber (SMA Connector)S200SMAS200SMA2018-07-11
M473S2720Trimedyne® FlexMax® 272 µm Single Use Holmium Bare FiberS272S2722018-07-11
M473S272SMA0Trimedyne® FlexMax® 272 µm Single Use Holmium Fiber (SMA Connector)S272SMAS272SMA2018-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
04053002150316Bare Fiber 400 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150415Bare Fiber 600 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
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