FDA.reportPublic FDA data

Endoscope sheath, reusable

Definition
A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.
GUDID devices
2,754
Last updated
2026-09-04 23:09:46

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04953170340741RIGID SHEATH FOR LTF-190-10-3DOLYMPUS MEDICAL SYSTEMS CORP.MAJ-20792016-09-21
04250337121657Working Tube with long lipJoimax GmbHWTS1615172026-08-19
04055207065730VERTEBRISRichard Wolf GmbH152082642022-11-01
00821925001480USA EliteGyrus ACMI, LLCCLO-232016-10-13
00821925001497USA EliteGyrus ACMI, LLCCLS-232016-10-13
00821925001602Elite 2 SystemGyrus ACMI, LLCE2RIS-CF272016-10-13
00821925001626Elite 2 SystemGyrus ACMI, LLCE2ROS-CF272016-10-13
00821925001657Elite 2 SystemGyrus ACMI, LLCE2RTO-CF252016-10-13
00821925001664Elite 2 SystemGyrus ACMI, LLCE2RTO-CF272016-10-13
00821925001671Elite 2 SystemGyrus ACMI, LLCE2RVO-CF252016-10-13
00821925001688Elite 2 SystemGyrus ACMI, LLCE2RVO-CF272016-10-13
00821925001695Elite 2 SystemGyrus ACMI, LLCE2TO-CF252016-10-13
00821925001701Elite 2 SystemGyrus ACMI, LLCE2TO-CF272016-10-13
00821925001718Elite 2 SystemGyrus ACMI, LLCE2VO-CF252016-10-13
00821925001862USA SeriesGyrus ACMI, LLCGY5-CFH2016-10-14
00821925001886USA EliteGyrus ACMI, LLCEIS-CFR-272016-10-13
00821925001923USA EliteGyrus ACMI, LLCEIWE-A2016-10-05
00821925002081USA EliteGyrus ACMI, LLCEOS-CFR-272016-10-14
00821925002104USA Elite SystemGyrus ACMI, LLCEOS-HCF272024-11-21
00821925002524USA SeriesGyrus ACMI, LLCGYD152016-10-14
00821925003408Elite 2 SystemGyrus ACMI, LLCE2OS-CF252016-10-13
00821925003484Elite 2 SystemGyrus ACMI, LLCE2RIS-CF252016-10-13
B382SD20260Surgical DirectSurgical Direct, Inc.SD2-0262026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.SD4131492026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.SD48-0084LH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.SD48-008SLH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.SD48-1014SLH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.SD48-1022LH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.SD48-3003-STR2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.SD48-7193-002026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.SD48-7223002026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.SD5235322026-08-03
B382SD161090Surgical DirectSurgical Direct, Inc.SD161092026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.SD30609CH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.SD316392026-07-31
B382SD48155416201210Surgical DirectSurgical Direct, Inc.SD4815541620-1212022-11-30
B382SD823090Surgical DirectSurgical Direct, Inc.SD823092020-04-28
B382SD306090Surgical DirectSurgical Direct, Inc.SD306092022-11-23
00886874116289NoneINTUITIVE SURGICAL, INC.4901072019-03-21
B382SD12711090Surgical DirectSurgical Direct, Inc.SD1271-1092026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.SD1271-392026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.SD1271-592026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.SD13018-772026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.SD23373492026-07-14
00888867101548Arthrex®ARTHREX, INC.AR-3370-00052018-06-28
00888867101555Arthrex®ARTHREX, INC.AR-3370-00072018-06-28
B382SD231090Surgical DirectSurgical Direct, Inc.SD231092020-04-25
B382SD233790Surgical DirectSurgical Direct, Inc.SD233792020-04-25
B382SD4120990Surgical DirectSurgical Direct, Inc.SD4120992020-04-27
00821925038318Blue SiliconeGyrus ACMI, LLCCS-B6122016-10-13
00821925038325Gyrus ACMIGyrus ACMI, LLCCS-G52016-10-13
00821925038332Gyrus ACMIGyrus ACMI, LLCCS-G72016-10-13
00840306802386Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.08-01652025-10-24
00888867354425Arthrex®ARTHREX, INC.AR-3300A2020-09-18
00888867354432Arthrex®ARTHREX, INC.AR-3300B2020-09-18
00888867431270Arthrex®ARTHREX, INC.AR-3373-42022024-01-09
00888867431287Arthrex®ARTHREX, INC.AR-3373-42012024-01-09
00888867431348Arthrex®ARTHREX, INC.AR-3370-4203A2024-01-09
00888867431355Arthrex®ARTHREX, INC.AR-3370-4203B2024-01-09
00888867446434Arthrex®ARTHREX, INC.AR-3380-4056H2024-01-09
00888867530003Arthrex®ARTHREX, INC.AR-S3420-R75-212OT2025-01-16
00888867530010Arthrex®ARTHREX, INC.AR-S3420-R80-212OT2025-01-16
00888867530027Arthrex®ARTHREX, INC.AR-S3420-R75-212ET2025-01-16
00888867530034Arthrex®ARTHREX, INC.AR-S3420-R80-212ET2025-01-16
04042761005241OlympusOLYMPUS Winter & Ibe GmbHA35512016-09-21
04042761005258OlympusOLYMPUS Winter & Ibe GmbHA35522016-09-21
04042761006637OlympusOLYMPUS Winter & Ibe GmbHA47602016-09-21
04042761006644OlympusOLYMPUS Winter & Ibe GmbHA47612016-09-21
04042761006705OlympusOLYMPUS Winter & Ibe GmbHA47702016-09-21
04042761006712OlympusOLYMPUS Winter & Ibe GmbHA47712016-09-21
04042761006729OlympusOLYMPUS Winter & Ibe GmbHA47722016-09-21
04042761006736OlympusOLYMPUS Winter & Ibe GmbHA47732016-09-21
04042761006743OlympusOLYMPUS Winter & Ibe GmbHA47752016-09-21
04042761006750OlympusOLYMPUS Winter & Ibe GmbHA47762016-09-21
04042761020237OlympusOLYMPUS Winter & Ibe GmbHA20911A2016-09-21
04042761020244OlympusOLYMPUS Winter & Ibe GmbHA20912A2016-09-21
04042761020251OlympusOLYMPUS Winter & Ibe GmbHA20913A2016-09-21
04042761020268OlympusOLYMPUS Winter & Ibe GmbHA20914A2016-09-21
04042761020275OlympusOLYMPUS Winter & Ibe GmbHA20915A2016-09-21
04042761020329OlympusOLYMPUS Winter & Ibe GmbHA20930A2016-09-21