FDA.reportPublic FDA data

GYN Robotic Handpiece Tray

Primary DI
00852306007050
Brand
GYN Robotic Handpiece Tray
Company
OMNIGUIDE, INC.
Model
GYN-TRAY-MIS
Catalog number
GYN-TRAY-MIS
Device description
Handpiece Tray for GYN - Robotic
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
00852306007050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852306007050008523060070508523060070500852306007050

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

Regulatory Flags#

DUNS number
030124221
Device count
1
Lot or batch
true
Manufacturing date on label
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
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16