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
2,735
Last updated
2026-08-12 10:12:16

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
04042761020336OlympusOLYMPUS Winter & Ibe GmbHA20931A2016-09-21
04042761020343OlympusOLYMPUS Winter & Ibe GmbHA20933A2016-09-21
04042761020350OlympusOLYMPUS Winter & Ibe GmbHA20934A2016-09-21
04042761020916OlympusOLYMPUS Winter & Ibe GmbHA22021A2016-09-21
04042761020923OlympusOLYMPUS Winter & Ibe GmbHA22022A2016-09-21
04042761020930OlympusOLYMPUS Winter & Ibe GmbHA22023A2016-09-21
04042761020961OlympusOLYMPUS Winter & Ibe GmbHA22041A2016-09-21
04042761020978OlympusOLYMPUS Winter & Ibe GmbHA22041T2016-09-21
04042761020985OlympusOLYMPUS Winter & Ibe GmbHA22042A2016-09-21
04042761020992OlympusOLYMPUS Winter & Ibe GmbHA22042T2016-09-21
04042761023207OlympusOLYMPUS Winter & Ibe GmbHA37022A2016-09-21
04042761023658OlympusOLYMPUS Winter & Ibe GmbHA42011A2016-09-21
04042761023665olympusOLYMPUS Winter & Ibe GmbHA42021A2016-09-21
04042761024105OlympusOLYMPUS Winter & Ibe GmbHA47610A2016-09-21
04042761029339OlympusOLYMPUS Winter & Ibe GmbHA22040A2016-09-21
04042761029346OlympusOLYMPUS Winter & Ibe GmbHA22026A2016-09-21
04042761029353OlympusOLYMPUS Winter & Ibe GmbHA22027A2016-09-21
04042761029360OlympusOLYMPUS Winter & Ibe GmbHA22040T2016-09-21
04042761030465OlympusOLYMPUS Winter & Ibe GmbHA20916A2016-09-21
04042761051514OlmypusOLYMPUS Winter & Ibe GmbHWA22017A2016-09-21
04042761051521OlympusOLYMPUS Winter & Ibe GmbHWA22017T2016-09-21
04042761051538OlympusOLYMPUS Winter & Ibe GmbHWA22018A2016-09-21