FDA.reportPublic FDA data

TRIO Handpiece

Primary DI
00852306007708
Brand
TRIO Handpiece
Company
OMNIGUIDE, INC.
Model
1
Catalog number
323000
Device description
The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact handheld disposable surgical instrument. It enables a surgeon to provide fluid suction, bipolar cautery and CO2 laser energy delivered via a flexible OmniGuide fiber for minimally invasive surgery. The handpiece is delivered sterile, and is intended for one-time use only. TRIO has been validated to be used with the Valleylab Triad or Valleylab Force FX.
Published
2019-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183199000TRIO HandpieceOmniguide, Inc.2019-05-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852306007708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852306007708008523060077088523060077080852306007708

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-666-4484customerservice@omni-guide.com

Regulatory Flags#

DUNS number
030124221
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852306007753OMNIGUIDE BeamPath OTO-U FiberOTO-UOTO-U2025-04-08
00894338002672BeamPath NEURO-L FiberNEURO-LNEURO-L2016-09-22
00894338002818BeamPath ROBOTIC fiberROBOTICROBOTIC2016-09-22
00894338002825Elevate™ ENT Elite Fiber3220013220012016-09-22
00894338002849Omniguide Select Fiber3220033220032016-09-20
00894338002856Velocity™ High Performance Fiber3320053320052016-09-22
10894338002693Gas Filter UnitACC-GFU-100ACC-GFU-1002016-09-22
00852306007715Beacon Advanced Energy CO2 Laser System60 Watt420060-AA2018-07-02
00894338002726FELS Laser SystemFELS-25AFELS-25A2016-09-22
00894338002009Elevate ENT Handpiece 5cm 0° -S3210173210172016-09-21
00894338002016Flexguide Ultra HandpieceFLEXGUIDE-ULTRAFLEXGUIDE-ULTRA2016-09-22
00894338002023Elevate™ENT Handpiece 7cm 0°-S3210023210022016-09-22
00894338002030Elevate™ENT Handpiece 7cm 25°-S3210033210032016-09-22
00894338002047BeamPath OTO-S fiberOTO-SOTO-S2016-09-22
00894338002054BeamPath OTO-M fiberOTO-MOTO-M2016-09-22
00894338002351Handpiece Tray for AccuBeam OtologyOTO-TRAYOTO-TRAY2016-09-22
00894338002740Elevate™ENT Handpiece 15cm 25°-S3210043210042016-09-22
00894338002771Elevate™ENT Handpiece 17cm 45°/0° -S3210053210052016-09-22
00894338002863Lapflex, Laparoscopic Articulating Handpiece- 33cm3410013410012016-09-22
00894338002870Elevate™ENT Handpiece 17cm 45°/30°3210063210062016-09-22

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