FDA.reportPublic FDA data

Medical equipment/instrument drape, single-use

Definition
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
GUDID devices
4,800
Last updated
2026-06-06 06:08:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00748426121861OLYMPUSMicrotek Medical LLCEquipment Drapes2026-05-28
07466532979338Moon SurgicalDAS Medical International SRL3002026-05-28
10665973027248DukalDukal LLC276072022-12-06
00840456201756JMUJMU DENTAL, INC481010012026-05-27
00840456201763JMUJMU DENTAL, INC481010022026-05-27
00840456201770JMUJMU DENTAL, INC481010032026-05-27
00840456201787JMUJMU DENTAL, INC481010042026-05-27
00840456201794JMUJMU DENTAL, INC481010052026-05-27
00840456221020JMUJMU DENTAL, INC481010062026-05-27
D125780MLB2Premium PlusPremium Plus (Dongguan) Limited780MLB2026-05-27
D125780MW2Premium PlusPremium Plus (Dongguan) Limited780MW2026-05-27
D125780SLB2Premium PlusPremium Plus (Dongguan) Limited780SLB2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) Limited780SW2026-05-27
00190769003555Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLC003552017-07-17
00192253020772CONVERTORSCardinal Health 200, LLC87202019-08-20
00195062075582AllrapKerr CorporationSGHC75C2025-06-13
00195062147104AllrapKerr CorporationSNG2980-75C2025-06-13
00195062147111AllrapKerr CorporationSNG4556-75C2025-06-13
00195062147128PinnacleKerr CorporationPCS150C2025-06-13
00195062147135PinnacleKerr CorporationPCS125C2025-06-13
00195062147142PinnacleKerr CorporationPSCXL75C2025-06-13
00195062147159PinnacleKerr CorporationNSC100C2025-06-13
00302730002348YoungYOUNG DENTAL MANUFACTURING I, LLC2958302022-10-16
00302730002355YoungYOUNG DENTAL MANUFACTURING I, LLC2958312022-10-16
00302730002362DenticatorYOUNG DENTAL MANUFACTURING I, LLC6700502022-10-16
00302730002379DenticatorYOUNG DENTAL MANUFACTURING I, LLC6702502022-10-16
00302730002386DenticatorYOUNG DENTAL MANUFACTURING I, LLC6703502022-10-16
00302730002393DenticatorYOUNG DENTAL MANUFACTURING I, LLC6704502022-10-16
00380650003881ALCONAlcon Laboratories, Inc.003806500038812024-07-02
00380650003904UNITYAlcon Laboratories, Inc.003806500039042025-04-08
00380650003911UNITYAlcon Laboratories, Inc.003806500039112025-04-08
00380650004185UNITYAlcon Laboratories, Inc.003806500041852025-04-08
00616258010229Avanta Hand Controller SheathBAYER MEDICAL CARE INC.AVA 500 HCS2019-05-20
00616258010236Display Control Unit Sheath BAYER MEDICAL CARE INC.AVA 500 DCOV 2019-05-20
00616258021546Avanta Hand Controller SheathBAYER MEDICAL CARE INC.AVA 500 HCS2019-10-25
00616258021553Display Control Unit Sheath BAYER MEDICAL CARE INC.AVA 500 DCOV 2019-10-25
00616258024868Display Control Unit SheathBayer Medical Care Inc.AVA 500 DCOV2024-05-06
00616258024905Avanta Hand Controller SheathBayer Medical Care Inc.AVA 500 HCS2024-05-06
00616784213620Disposable BP Cuff Barrier SleevesDynarex Corporation21362022-04-23
00616784215129Half Chair CoverDynarex Corporation21512021-09-01
00616784215228Full Chair CoverDynarex Corporation21522021-09-01
00616784215327Plastic Headrest CoversDynarex Corporation21532021-09-01
00616784215426Plastic Headrest CoversDynarex Corporation21542021-09-01
00616784215921Tray SleevesDynarex Corporation21592021-09-01
00616784216027Tray SleevesDynarex Corporation21602021-09-01
00616784216126Plastic Cord CoversDynarex Corporation21612021-09-01
00616784216225Machine BagDynarex Corporation21622021-09-01
00616784216423"Bottle Covers, Medium, 6"" x 8"" "Dynarex Corporation21642025-10-03
00616784216522"Bottle Covers, Large, 6"" x 10"" "Dynarex Corporation21652025-10-03
00618125102273TIDISHIELDTIDI PRODUCTS, LLC208192021-05-06
00618125102310TIDISHIELDTIDI PRODUCTS, LLC208242021-05-06
00618125102327TIDITIDI PRODUCTS, LLC208252022-10-07
00618125102419TIDISHIELDTIDI PRODUCTS, LLC208412021-05-06
00618125102464Vital SignsTIDI PRODUCTS, LLC208492022-10-21
00618125102495TIDISHIELDTIDI PRODUCTS, LLC208552021-05-06
00618125102501TIDISHIELDTIDI PRODUCTS, LLC208562021-05-06
00618125102518TIDISHIELDTIDI PRODUCTS, LLC208612021-05-06
00618125102549TIDISHIELDTIDI PRODUCTS, LLC208672021-05-06
00618125102556TIDISHIELDTIDI PRODUCTS, LLC208682021-05-06
00618125112463SironaTIDI PRODUCTS, LLC208902022-10-07
00618125112906TIDISHIELDTIDI PRODUCTS, LLC208932021-05-06
00618125113057DelascoTIDI PRODUCTS, LLC208982022-10-18
00618125113309SironaTIDI PRODUCTS, LLC209042022-10-07
00618125113385TIDISHIELDTIDI PRODUCTS, LLC209052021-05-06
00618125114856Henry ScheinTIDI PRODUCTS, LLC209122022-10-18
00618125115259SironaTIDI PRODUCTS, LLC209672022-10-12
00618125115808TIDISHIELDTIDI PRODUCTS, LLC209162021-05-06
00618125116409TIDISHIELDTIDI PRODUCTS, LLC209682021-05-06
00618125116652TIDISHIELDTIDI PRODUCTS, LLC209692021-05-06
00618125116829TIDISHIELDTIDI PRODUCTS, LLC209702021-05-06
00618125116973Vital SignsTIDI PRODUCTS, LLC20849A2022-10-21
00618125119202Kavowerk Dentale EinrichtungenTIDI PRODUCTS, LLC209262022-10-07
00618125119219Air TechniquesTIDI PRODUCTS, LLC209272022-10-12
00618125120949TPC Advanced TechnologyTIDI PRODUCTS, LLC209302022-10-12
00618125121014TIDISHIELDTIDI PRODUCTS, LLC209322021-05-06
00618125121083SoproTIDI PRODUCTS, LLC209412022-10-12
00618125122196TIDISHIELDTIDI PRODUCTS, LLC209782021-05-06
00618125122202TIDISHIELDTIDI PRODUCTS, LLC209792021-05-06
00618125122240TIDISHIELDTIDI PRODUCTS, LLC209812021-05-06
00618125123469TIDITIDI PRODUCTS, LLC9150022022-10-18