FDA.reportPublic FDA data

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
134
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00380657400034OcutomeAlcon Laboratories, Inc.10062016-09-24
00380657410170Total Plus, Accurus, AlconAlcon Laboratories, Inc.80657410172016-09-24
00380657410187Accurus, AlconAlcon Laboratories, Inc.80657410182016-09-24
00380657508211Accurus, AlconAlcon Laboratories, Inc.80657508212016-09-24
00380657509485CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657509482020-01-16
00380657509492CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657509492020-01-16
00380657509508CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657509502020-01-16
0038065751020720 GA ULTRAVITAlcon Laboratories, Inc.80657510202016-09-24
00380657510542LaureateAlcon Laboratories, Inc.80657510542016-09-24
00380657510573Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510572016-09-24
00380657510580Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510582016-09-24
00380657510634Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510632016-09-24
00380657510764Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510762016-09-24
00380657510771Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510772016-09-24
00380657510795Constellation, Ultravit, TotalPlus, EngaugeAlcon Laboratories, Inc.80657510792016-09-24
00380657511228Accurus, 25+, AlconAlcon Laboratories, Inc.80657511222016-09-24
00380657511365LaureateAlcon Laboratories, Inc.80657511362016-09-24
00380657511556ConstellationAlcon Laboratories, Inc.80657511552016-09-24
00380657511587ConstellationAlcon Laboratories, Inc.80657511582016-09-24
00380657511631ConstellationAlcon Laboratories, Inc.80657511632016-09-24
0038065751165525+Alcon Laboratories, Inc.80657511652016-09-24
00380657511839AlconAlcon Laboratories, Inc.80657511832016-09-24
00380657511846EngaugeAlcon Laboratories, Inc.80657511842016-09-24
00380657511853EngaugeAlcon Laboratories, Inc.80657511852016-09-24
00380657511860AlconAlcon Laboratories, Inc.80657511862016-09-24
00380657511969Alcon, Infiniti, UltraVitAlcon Laboratories, Inc.80657511962016-09-24
00380657514380CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657514382020-01-16
00380657514410EngaugeAlcon Laboratories, Inc.80657514412016-09-24
00380657514427AlconAlcon Laboratories, Inc.80657514422016-09-24
00380657515721EngaugeAlcon Laboratories, Inc.80657515722016-09-24
00380657515745AlconAlcon Laboratories, Inc.80657515742016-09-24
00380657515752AlconAlcon Laboratories, Inc.80657515752016-09-24
00380657515769EngaugeAlcon Laboratories, Inc.80657515762016-09-24
00380657517008CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657517002020-01-16
00380657517015EngaugeAlcon Laboratories, Inc.80657517012016-09-24
00380657517046CONSTELLATION® ULTRAVIT® ENGAUGE®Alcon Laboratories, Inc.80657517042020-01-16
00380657517053EngaugeAlcon Laboratories, Inc.80657517052016-09-24
00380657517060AlconAlcon Laboratories, Inc.80657517062016-09-24
00380657517152Constellation, Ultravit, 25+, TotalPlus, EngaugeAlcon Laboratories, Inc.80657517152016-09-24
0038065752125827+® Infusion Cannula w/TrayAlcon Laboratories, Inc.80657521252016-09-24
00380657521340Alcon, Centurion, UltravitAlcon Laboratories, Inc.80657521342016-09-24
00380657521500AlconAlcon Laboratories, Inc.80657521502016-09-24
0038065752173927+® Infusion Cannula w/TrayAlcon Laboratories, Inc.80657521732016-09-24
00380657524136Constellation, ULTRAVIT, EngaugeAlcon Laboratories, Inc.80657524132017-06-29
00380657524150Constellation, ULTRAVIT, Engauge, 25+Alcon Laboratories, Inc.80657524152017-06-29
00380657524174Constellation, ULTRAVIT, Engauge, 27+Alcon Laboratories, Inc.80657524172017-06-29
00380657524358Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524352018-07-19
00380657524365Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524362018-07-19
00380657524372Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524372018-07-19
00380657524389Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524382018-07-19
00380657524396Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524392018-07-19
00380657524488Constellation, ULTRAVIT, EdgePlus, TotalPlusAlcon Laboratories, Inc.80657524482017-06-29
00380657524495Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524492018-07-19
00380657524501Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524502018-07-19
00380657524518Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITAlcon Laboratories, Inc.80657524512018-07-19
00380657524525Constellation, ULTRAVIT, EdgePlus, TotalPlusAlcon Laboratories, Inc.80657524522017-06-29
00380657529001CENTURION, InterpidAlcon Laboratories, Inc.80657529002017-06-29
00380658300227CONSTELLATION® HYPERVIT® ENGAUGE®Alcon Laboratories, Inc.80658300222020-01-16
00380658300234CONSTELLATION® HYPERVIT® ENGAUGE®Alcon Laboratories, Inc.80658300232020-01-16
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