Trimedyne® Reposable OmniTip™ Switchable Tip - 30°

Primary DI
M47320476MHP1
Brand
Trimedyne® Reposable OmniTip™ Switchable Tip - 30°
Company
TRIMEDYNE, INC.
Model
20476M-HP
Catalog number
20476M-HP
Device description
Multiuse Switchable Tip, Omni HP System, 30 degree
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
false

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
M47320476MHP1PackageHIBCC5In Commercial Distribution
M47320476MHP0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Ethylene Oxide

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
true

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

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