FDA.reportPublic FDA data

Endoscope sheath, single-use

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 single-use device.
GUDID devices
384
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00818501022397Clearview Scope CoverINVOTEC INTERNATIONAL, INC.28-360002022-12-06
00850012846222JNW URTRAC™LSI Solutions, Inc.0813002022-03-07
00850012846451JNW URTRACLSI Solutions, Inc.0813002025-06-06
00853277008053LUMINELLE DTx 360 Rigid Rotatable Disposable SheathUVISION 360, INC.LUMDTx-360R2019-06-17
00879123001528GlideScope®Verathon Medical (Canada) ULCGVL® 1 Stat2022-12-08
00879123001535GlideScope®Verathon Medical (Canada) ULCGVL® 2 Stat2022-12-08
00879123001566GlideScope®Verathon Medical (Canada) ULCGVL® 3 Stat2022-12-08
00879123001573GlideScope®Verathon Medical (Canada) ULCGVL® 4 Stat2022-12-08
00879123001986GlideScope®Verathon Medical (Canada) ULCGVL® 0 Stat2022-12-08
00879123002600GlideScope®Verathon Medical (Canada) ULCGVL® 2.5 Stat2022-12-08
00879123008381GlideScope®Verathon Medical (Canada) ULCClearFit™ Hyperangle 3 Cover2025-08-01
00879123008398GlideScope®Verathon Medical (Canada) ULCClearFit™ Hyperangle 4 Cover2025-08-01
00879123008428GlideScope®Verathon Medical (Canada) ULCClearFit™ Miller 2 Cover2025-08-01
00879123008442GlideScope®Verathon Medical (Canada) ULCClearFit™ MAC 2 Cover2025-08-01
00879123008459GlideScope®Verathon Medical (Canada) ULCClearFit™ MAC 3 Cover2025-08-01
00879123008466GlideScope®Verathon Medical (Canada) ULCClearFit™ MAC 4 Cover2025-08-01
05060602250314Protech LMEDITECH ENDOSCOPY LTDINOV8-028L2026-01-28
05060602250321Protech SMEDITECH ENDOSCOPY LTDINOV8-028S2026-01-30
05060602250567Protech XLMEDITECH ENDOSCOPY LTDINOV8-0442026-01-30
05060768280040Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)SURGEASE INNOVATIONS LIMITEDLX1-CCS-2022026-05-13
05060768280231Consumable Pack (Sheath, Obturator & Manifold)SURGEASE INNOVATIONS LIMITEDLX1-CSB-2012026-05-13
05060768280736Large LumenEye x1 Manifold -26mm SURGEASE INNOVATIONS LIMITEDLX1-LMB-2612026-05-13
05060768280750Large LumenEye x1 Manifold -30mm SURGEASE INNOVATIONS LIMITEDLX1-LMB-3012026-05-13
06925816657511ClearPetraWell Lead Medical Co.,LtdU04A1010262026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdU04A1011262026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdU04A1012262026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdU04A1013262026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdU04A1010362026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdU04A1011362026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdU04A1012362026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdU04A1013362026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdU04A1010402026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdU04A1011402026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdU04A1012402026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdU04A1013402026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdU04A1010462026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdU04A1011462026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdU04A1012462026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdU04A1013462026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdU04A1010502026-01-26
06925816657689ClearPetraWell Lead Medical Co.,LtdU04A1011502026-01-26
06925816657696ClearPetraWell Lead Medical Co.,LtdU04A1012502026-01-26
06925816657702ClearPetraWell Lead Medical Co.,LtdU04A1013502026-01-26
06925816657719ClearPetraWell Lead Medical Co.,LtdU04A1010552026-01-26
06925816657726ClearPetraWell Lead Medical Co.,LtdU04A1011552026-01-26
06925816657733ClearPetraWell Lead Medical Co.,LtdU04A1012552026-01-26
06925816657740ClearPetraWell Lead Medical Co.,LtdU04A1013552026-01-26
06925816667213ClearPetraWell Lead Medical Co.,LtdU04A1010262026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdU04A1011262026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdU04A1012262026-03-16
06944932739970ClearPetraWell Lead Medical Co.,Ltd901110132020-12-04
06944932739987ClearPetraWell Lead Medical Co.,Ltd901111132020-12-04
06944932739994ClearPetraWell Lead Medical Co.,Ltd901112132020-12-04
06944932740006ClearPetraWell Lead Medical Co.,Ltd901113132020-12-04
06944932740013ClearPetraWell Lead Medical Co.,Ltd901114132020-12-04
06944932740020ClearPetraWell Lead Medical Co.,Ltd901110262020-12-04
06944932740037ClearPetraWell Lead Medical Co.,Ltd901111262020-12-04
06944932740044ClearPetraWell Lead Medical Co.,Ltd901112262020-12-04
06944932740051ClearPetraWell Lead Medical Co.,Ltd901113262020-12-04
06944932740068ClearPetraWell Lead Medical Co.,Ltd901114262020-12-04
06944932740075ClearPetraWell Lead Medical Co.,Ltd901110362020-12-04
06944932740082ClearPetraWell Lead Medical Co.,Ltd901111362020-12-04
06944932740099ClearPetraWell Lead Medical Co.,Ltd901112362020-12-04
06944932740105ClearPetraWell Lead Medical Co.,Ltd901113362020-12-04
06944932740112ClearPetraWell Lead Medical Co.,Ltd901114362020-12-04
06944932740129ClearPetraWell Lead Medical Co.,Ltd901110402020-12-04
06944932740136ClearPetraWell Lead Medical Co.,Ltd901111402020-12-04
06944932740143ClearPetraWell Lead Medical Co.,Ltd901112402020-12-04
06944932740150ClearPetraWell Lead Medical Co.,Ltd901113402020-12-04
06944932740167ClearPetraWell Lead Medical Co.,Ltd901114402020-12-04
06944932740174ClearPetraWell Lead Medical Co.,Ltd901110462020-12-04
06944932740181ClearPetraWell Lead Medical Co.,Ltd901111462020-12-04
06944932740198ClearPetraWell Lead Medical Co.,Ltd901112462020-12-04
06944932740204ClearPetraWell Lead Medical Co.,Ltd901113462020-12-04
06944932740211ClearPetraWell Lead Medical Co.,Ltd901114462020-12-04
06944932740228ClearPetraWell Lead Medical Co.,Ltd901110552020-12-04
06944932740235ClearPetraWell Lead Medical Co.,Ltd901111552020-12-04
06944932740242ClearPetraWell Lead Medical Co.,Ltd901112552020-12-04
06944932740259ClearPetraWell Lead Medical Co.,Ltd901113552020-12-04
06944932740266ClearPetraWell Lead Medical Co.,Ltd901114552020-12-04