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
396
Last updated
2026-10-24 13:17:19

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
25056094505319PROACT VLSPROACT MEDICAL LIMITEDNPRVPED12026-10-14
25056094505326PROACT VLSPROACT MEDICAL LIMITEDNPRVPED22026-10-14
25056094505333PROACT VLSPROACT MEDICAL LIMITEDNPRVMAC22026-10-14
25056094505340PROACT VLSPROACT MEDICAL LIMITEDNPRVMAC32026-10-14
25056094505357PROACT VLSPROACT MEDICAL LIMITEDNPRVMAC42026-10-14
25056094505364PROACT VLSPROACT MEDICAL LIMITEDNPRVMAC3DA2026-10-14
25056094505371PROACT VLSPROACT MEDICAL LIMITEDNPRVMAC4DA2026-10-14
25056094505395PROACT VLSPROACT MEDICAL LIMITEDNPRVNEOMAC12026-10-14
25056094505401PROACT VLSPROACT MEDICAL LIMITEDNPRVNEOMIL02026-10-14
25056094505418PROACT VLSPROACT MEDICAL LIMITEDNPRVNEOMIL002026-10-14
25056094505425PROACT VLSPROACT MEDICAL LIMITEDNPRVNEOMIL12026-10-14
00850012846741JNW URTRACLSI Solutions, Inc.0813002026-08-21
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