FDA.reportPublic FDA data

Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber, 5m Length

Primary DI
M473B2005M0
Brand
Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber, 5m Length
Company
TRIMEDYNE, INC.
Model
B200-5M
Catalog number
B200-5M
Device description
Fiber, Bare, 200um, Reusable, TMED Connector, 5m long
Published
2018-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
M473B2005M0PrimaryHIBCC0

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""]"
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8007335273customerservice@trimedyne.com

Regulatory Flags#

DUNS number
057007239
Device count
1
Lot or batch
true
Expiration date on label
true
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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