FDA.report

Vitrectomy system handpiece

Definition
A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.
GUDID devices
75
Last updated
2024-07-10 09:37:08

Related Product Codes

CodeDeviceSpecialtyClassDevices
HQCUnit, PhacofragmentationOphthalmic242
MLZVitrectomy, Instrument CutterOphthalmic217
HKPInstrument, Vitreous Aspiration And Cutting, Battery-PoweredOphthalmic211
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic25

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00380650002150UNITYAlcon Laboratories, Inc.003806500021502024-07-02
10380657509482CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657509482020-01-16
10380657509499CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657509492020-01-16
10380657509505CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657509502020-01-16
10380657514387CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657514382020-01-16
10380657517005CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657517002020-01-16
10380657517043CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657517042020-01-16
10380658300224CONSTELLATION® HYPERVIT® ENGAUGE®Alcon Laboratories, Inc.80658300222020-01-16
10380658300231CONSTELLATION® HYPERVIT® ENGAUGE®Alcon Laboratories, Inc.80658300232020-01-16
05050474500204AMO VITREPURE VITRECTOMY HANDPIECES ANDJOHNSON & JOHNSON SURGICAL VISION, INC.OPO392016-09-02
05050474520479AMO TAC VITRECTOMY HANDPIECEJOHNSON & JOHNSON SURGICAL VISION, INC.OM0201011D2016-09-02
05050474520493AMO LIMBAL NEEDLE ASSEMBLYJOHNSON & JOHNSON SURGICAL VISION, INC.OM05040112016-09-02
05050474520509AMO TAC INFUSION SLEEVEJOHNSON & JOHNSON SURGICAL VISION, INC.OM05270112016-09-02
05050474534094DISPOSABLE 20GA VITRECTOMY CUTTER & IRRIJOHNSON & JOHNSON SURGICAL VISION, INC.NGP00202016-09-02
05050474534100DISPOSABLE 23GA VITRECTOMY CUTTERJOHNSON & JOHNSON SURGICAL VISION, INC.NGP00232016-09-02
05050474534117DISPOSABLE 25GA VITRECTOMY CUTTERJOHNSON & JOHNSON SURGICAL VISION, INC.NGP00252016-09-02
00856222004193INTRECTOR®INSIGHT INSTRUMENTS, INC.711012016-09-23
00812480010215NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.4420CE2016-09-23
00812480010222NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.4425CE2016-09-23
00812480010277NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.4422CE2016-09-23
00812480010307NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.4625CE2017-06-24
00812480010314NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.4630CE2017-06-24
00812480010956NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.2355CE2016-09-23
00812480010963NAMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.2405CE2016-09-23
10380657400031OcutomeAlcon Laboratories, Inc.10062016-09-24
10380657410177Total Plus, Accurus, AlconAlcon Laboratories, Inc.80657410172016-09-24
10380657410184Accurus, AlconAlcon Laboratories, Inc.80657410182016-09-24
10380657508218Accurus, AlconAlcon Laboratories, Inc.80657508212016-09-24
1038065751020420 GA ULTRAVITAlcon Laboratories, Inc.80657510202016-09-24
10380657510549LaureateAlcon Laboratories, Inc.80657510542016-09-24
10380657510570Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510572016-09-24
10380657510587Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510582016-09-24
10380657510631Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510632016-09-24
10380657510761Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510762016-09-24
10380657510778Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510772016-09-24
10380657510792Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510792016-09-24
10380657511225Accurus, 25+, AlconAlcon Laboratories, Inc.80657511222016-09-24
10380657511362LaureateAlcon Laboratories, Inc.80657511362016-09-24
10380657511553ConstellationAlcon Laboratories, Inc.80657511552016-09-24
10380657511584ConstellationAlcon Laboratories, Inc.80657511582016-09-24
10380657511638ConstellationAlcon Laboratories, Inc.80657511632016-09-24
1038065751165225+Alcon Laboratories, Inc.80657511652016-09-24
10380657511836AlconAlcon Laboratories, Inc.80657511832016-09-24
10380657511843EngaugeAlcon Laboratories, Inc.80657511842016-09-24
10380657511850EngaugeAlcon Laboratories, Inc.80657511852016-09-24
10380657511867AlconAlcon Laboratories, Inc.80657511862016-09-24
10380657511966Alcon, Infiniti, UltraVitAlcon Laboratories, Inc.80657511962016-09-24
10380657514417EngaugeAlcon Laboratories, Inc.80657514412016-09-24
10380657514424AlconAlcon Laboratories, Inc.80657514422016-09-24
10380657515728EngaugeAlcon Laboratories, Inc.80657515722016-09-24
10380657515742AlconAlcon Laboratories, Inc.80657515742016-09-24
10380657515759AlconAlcon Laboratories, Inc.80657515752016-09-24
10380657515766EngaugeAlcon Laboratories, Inc.80657515762016-09-24
10380657517012EngaugeAlcon Laboratories, Inc.80657517012016-09-24
10380657517050EngaugeAlcon Laboratories, Inc.80657517052016-09-24
10380657517067AlconAlcon Laboratories, Inc.80657517062016-09-24
10380657517159Constellation, Ultravit, 25+, TotalPlus, EngaugeAlcon Laboratories, Inc.80657517152016-09-24
1038065752125527+® Infusion Cannula w/TrayAlcon Laboratories, Inc.80657521252016-09-24
10380657521347Alcon, Centurion, UltravitAlcon Laboratories, Inc.80657521342016-09-24
10380657521507AlconAlcon Laboratories, Inc.80657521502016-09-24
1038065752173627+® Infusion Cannula w/TrayAlcon Laboratories, Inc.80657521732016-09-24
10380657524133Constellation, ULTRAVIT, EngaugeAlcon Laboratories, Inc.80657524132017-06-29
10380657524157Constellation, ULTRAVIT, Engauge, 25+Alcon Laboratories, Inc.80657524152017-06-29
10380657524171Constellation, ULTRAVIT, Engauge, 27+Alcon Laboratories, Inc.80657524172017-06-29
10380657524355Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524352018-07-19
10380657524362Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524362018-07-19
10380657524379Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524372018-07-19
10380657524386Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524382018-07-19
10380657524393Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524392018-07-19
10380657524485Constellation, ULTRAVIT, EdgePlus, TotalPlusAlcon Laboratories, Inc.80657524482017-06-29
10380657524492Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524492018-07-19
10380657524508Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524502018-07-19
10380657524515Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524512018-07-19
10380657524522Constellation, ULTRAVIT, EdgePlus, TotalPlusAlcon Laboratories, Inc.80657524522017-06-29
10380657529008CENTURION, InterpidAlcon Laboratories, Inc.80657529002017-06-29