FDA.report

ENT shaver system

Definition
An assembly of mains electricity (AC-powered) devices designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It typically consists of a power supply transformer/control unit with operational controls, setting display, electrical connecting cables, and a rotary handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotary instruments. Some types may have dedicated software intended to provide optimal parameters for the procedure. An irrigation/suction system may be included.
GUDID devices
60
Last updated
2024-10-22 08:31:14

Related Product Codes

CodeDeviceSpecialtyClassDevices
EQJBur, Ear, Nose And ThroatEar, Nose, Throat122
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat218
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery217
HAWNeurological Stereotaxic InstrumentNeurology23

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
04048551071601UNIDRIVEKarl Storz GmbH & Co. KG20711620-12016-09-23
04048551159439n.a.Karl Storz GmbH & Co. KG40201RN2016-09-23
B504ES62902080250StrykerProvision6290-208-0252024-09-30
B504ES701380150Gyrus ACMIProvision701380152024-08-12
B504ES701380160Gyrus ACMIProvision701380162024-08-12
00821925043077DIEGO ELITEGyrus Acmi, Inc.BB4000SC2024-07-25
00821925043121DIEGO ELITEGyrus Acmi, Inc.BB4040XC2024-07-25
00821925043091DIEGO ELITEGyrus Acmi, Inc.BB4040SC2024-07-24
00821925043138DIEGO ELITEGyrus Acmi, Inc.MB4000SC2024-07-24
00821925043152DIEGO ELITEGyrus Acmi, Inc.MM4000SC2024-07-24
00821925043176DIEGO ELITEGyrus Acmi, Inc.MS4000SC2024-07-24
B504ES1884015RTD0MedtronicProvision1884015RTD2024-05-22
B504ES1885078HSE0MedtronicProvision1885078HSE2024-05-22
B504ES701380040Gyrus ACMIProvision701380042024-05-13
B504ES701380180Gyrus ACMIProvision701380182024-05-13
B504ES1883070BLD0MedtronicProvision1883070BLD2024-03-28
B504ES1883264HS0MedtronicProvision1883264HS2024-03-28
B504ES18829160MedtronicProvision18829162024-02-14
B504ES41304KKB0Karl StorzProvision41304KKB2024-02-14
B504ES62901120400StrykerProvision6290-112-0402024-02-14
B504ES52900110000StrykerProvision5290-011-0002024-01-16
B504ES701380000Gyrus ACMIProvision701380002023-08-30
B504ES701381000Gyrus ACMIProvision701381002023-08-30
B504ESSSB1236010Entellus MedicalProvisionSSB-12360-12023-08-28
B504ES18820400MedtronicProvision18820402023-06-19
B504ES18829400MedtronicProvision18829402023-06-19
B504ES18840040MedtronicProvision18840042023-06-08
B504ES52906280000StrykerProvision5290-628-0002023-06-08
B504ES52906350000StrykerProvision5290-635-0002023-06-08
J00717003000011Set OSSEOUNO + S120Bien-Air Surgery SA17003002019-01-07
00857326005635Shaver SystemENTELLUS MEDICAL, INC.SS-1002020-09-24
00821925011434TURBO 7000 FOOTSWITCHGyrus Acmi, Inc.703370042017-05-11
00821925011441DIEGO POWER DISSECTOR CONSOLEGyrus Acmi, Inc.703380002017-05-11
00821925022829MOD SYN 90 DEG FOR DIEGOGyrus Acmi, Inc.70921849D2017-05-11
00821925026070DIEGO POWER DISSECTOR CONSOLE REFURBISHEDGyrus Acmi, Inc.70338000R2017-05-11
00821925026148DIEGO® STARLINK HANDPIECE FOR USE W/BRAINLAB IGS SYSTEMSGyrus Acmi, Inc.703380102016-10-12
00821925026155DIEGO POWERED DISSECTOR FOOTSWITCHGyrus Acmi, Inc.703380112016-10-12
00821925026162DIEGO POWERED DISSECTOR FOOTSWITCH REFURBISHEDGyrus Acmi, Inc.70338011R2016-10-06
00821925026179DIEGO UNIVERSAL IGS ADAPTER SMALL STAINLESS STEELGyrus Acmi, Inc.703380122016-10-06
00821925026186DIEGO UNIVERSAL IGS ADAPTER LARGE STAINLESS STEELGyrus Acmi, Inc.703380132016-10-12
00821925027749MULTIDEBRIDER HANDPIECE, ANGLED DIEGO ELITEGyrus Acmi, Inc.MDHP100A2016-10-14
00821925027756MULTIDEBRIDER HANDPIECE, STRAIGHT DIEGO ELITEGyrus Acmi, Inc.MDHP100S2016-10-05
00821925027770POWER CONSOLE DIEGO ELITEGyrus Acmi, Inc.MDCONS1002016-10-14
00821925027787FOOTSWITCH DIEGO ELITEGyrus Acmi, Inc.MDFS1002016-10-14
00821925027794SUCTION MODULE, 110 VAC DIEGO ELITEGyrus Acmi, Inc.MDSM110V2017-05-11
00821925027800SUCTION MODULE, 220 VAC DIEGO ELITEGyrus Acmi, Inc.MDSM220V2017-05-11
00821925028715SHORT IRRIGATION REPLACEMENT MODULEGyrus Acmi, Inc.703255522017-05-11
00821925028722LONG IRRIGATION REPLACEMENT MODULEGyrus Acmi, Inc.703255532017-05-11
00821925028746DIEGO POWER DISSECTOR CONSOLE TRIGGER SWITCH ENABLEDGyrus Acmi, Inc.703390002016-10-06
00821925026223DIEGO SUCTION-IRRIGATION TUBING SET, DISPOSABLE 12'(3.66 m) LENGTH NGyrus Acmi, Inc.703380032016-10-12
00821925026254DIEGO TRIGGER SWITCH STERILE, DISPOSABLEGyrus Acmi, Inc.703380082016-10-12
00821925026131DIEGO HANDPIECE CLEANING KIT NONSTERILE .475"(12.07mm) DIA and .437"Gyrus Acmi, Inc.703380092016-10-12
00821925026247DIEGO OTOLOGY TUBE SET FOR USE WITH VIPER HANDPIECES 40" (101.6 cm)LGyrus Acmi, Inc.703380072016-10-06
00821925027817DIEGO ELITE TUBESET, STANDARDGyrus Acmi, Inc.TS100S2016-10-18
00821925027824DIEGO ELITE TUBESET, DECLOGGyrus Acmi, Inc.TS101DC2016-10-18
00821925027268DIEGO IRRIGATION TUBE SET FOR USE WITH VIPER HANDPIECES 12'(3.66 m)Gyrus Acmi, Inc.703369002017-05-11
00821925027831TUBESET WITH FILTER FOR SUCTION MODULE DIEGO ELITEGyrus Acmi, Inc.TS102SF2016-10-06
00821925040694Nosecone Adapter Grip Diego EliteGyrus Acmi, Inc.NCGRIP2016-10-05
00821925042346BRACKET EM COMPATIBLE DIEGO ELITEGyrus Acmi, Inc.BEMTS101DC2016-10-05
00821925042360DIEGO POWER DISSECTOR REFURBISHED CONSOLE TRIGGER SWITCH ENABLEDGyrus Acmi, Inc.70339000R2016-10-06