FDA.reportPublic FDA data

Trimedyne® Omni™ Sterilization Tray System

Primary DI
M47372050
Brand
Trimedyne® Omni™ Sterilization Tray System
Company
TRIMEDYNE, INC.
Model
7205
Catalog number
7205
Device description
Omni Sterilization Tray System
Published
2018-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M47372050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007335273customerservice@trimedyne.com

Regulatory Flags#

DUNS number
057007239
Device count
1
Lot or batch
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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