FDA.reportPublic FDA data

Elevate™ENT Handpiece 22cm 45°/30° -S

Primary DI
00894338002924
Brand
Elevate™ENT Handpiece 22cm 45°/30° -S
Company
OMNIGUIDE, INC.
Model
321011
Catalog number
321011
Device description
Elevate™ENT Handpiece
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081939000OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAYOmniguide, Inc.2008-08-12GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894338002924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894338002924008943380029248943380029240894338002924

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, reusableA flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications [e.g., to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas), to heat/ablate mucosal tissue to treat vaginal laxity]. It is designed to direct laser light from a laser generator to the surgical site and may be available in a variety of configurations/technologies (using, e.g., fibreoptic materials, specialized mirrors). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
030124221
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852306007753OMNIGUIDE BeamPath OTO-U FiberOTO-UOTO-U2025-04-08
00852306007708TRIO Handpiece13230002019-06-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14