FDA.reportPublic FDA data

Medical equipment drape, single-use

Definition
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, 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
190
Last updated
2024-08-27 08:58:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840343716820FusionMaxSURGIX MEDICAL LLC33501DC-0012024-08-19
00840343717544FusionMaxSURGIX MEDICAL LLC33501DC-0022024-08-19
00840343717551FusionMaxSURGIX MEDICAL LLC33501DC-0032024-08-19
00840343717568FusionMaxSURGIX MEDICAL LLC33501DC-0042024-08-19
00840343717575FusionMaxSURGIX MEDICAL LLC33501DC-0052024-08-19
00840343717582FusionMaxSURGIX MEDICAL LLC33501DC-0062024-08-19
00840343717599FusionMaxSURGIX MEDICAL LLC33501DC-0072024-08-19
10840343716827FusionMaxSURGIX MEDICAL LLC33501DC2024-08-19
00723896026632PRACTIFILM BARRIER FILM BLUEPRACTICON, INC.7158236 BLU2024-08-07
00723896026663PRACTIFILM BARRIER FILM BLACKPRACTICON, INC.7158236 BLA2024-08-07
00723896026694PRACTIFILM BARRIER FILM CLEARPRACTICON, INC.7158236 CLE2024-08-07
00723896026724PRACTIFILM BARRIER FILM GREENPRACTICON, INC.7158236 GRE2024-08-07
00723896026755PRACTIFILM BARRIER FILM MAGENTAPRACTICON, INC.7158236 MAG2024-08-07
00723896026786PRACTIFILM BARRIER FILM PURPLEPRACTICON, INC.7158236 PUR2024-08-07
10810101310369DinamicORPaneffort, LLC111-32232024-08-05
10810101311113DinamicORPaneffort, LLC111-21122024-08-05
04048438005170n.a.Karl Storz GmbH & Co. KG041150-202018-08-21
00810075281453BoneFoamBONE FOAM, INC.925.PC-DBC-BX202024-07-19
00089904009531Action®ACTION PRODUCTS, INC.Disposable Cover2021-01-14
00089904009548Action®ACTION PRODUCTS, INC.Disposable Cover2021-01-14
00089904009555Action®ACTION PRODUCTS, INC.Disposable Cover2021-01-14
00089904009562Action®ACTION PRODUCTS, INC.Disposable Cover2021-01-14
00089904009579Action®ACTION PRODUCTS, INC.Disposable Cover2021-01-14
00089904009586Action®ACTION PRODUCTS, INC.Disposable Cover2021-01-14
10618125190789OECTIDI PRODUCTS, LLC310462023-01-17
10618125190802OECTIDI PRODUCTS, LLC310482023-01-17
10618125190826OECTIDI PRODUCTS, LLC310472023-01-17
80683534080616A PlusA PLUS INTERNATIONAL INC.12022-12-21
2078755100610450300 EZ Cover Foot Pedal Bag w/ Large ButtonXODUS MEDICAL, INC.503002022-12-08
008171690234183D Green by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGR-SSCL2023-01-09
008171690234253D Green by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGR-HRSM2023-01-09
008171690234323D Green by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGR-HRLG2023-01-09
008171690234493D Green by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGR-HCS2023-01-09
008171690234563D Green by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCGR-BLK2023-01-09
00817169024651Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCHRCB-132023-01-09
00817169024668Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCHRCW-10 2023-01-09
00817169024675Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCHRCW-132023-01-09
00840348525694AADCOAADCO MEDICAL, INC.DB-1922CF1002022-12-19
00840348525700AADCOAADCO MEDICAL, INC.DB-1922CF1K2022-12-19
00840348525762AADCOAADCO MEDICAL, INC.DB-2620N2022-12-19
00840348525779AADCOAADCO MEDICAL, INC.DB-2820N2022-12-19
10841912106049System CoverPROTEK MEDICAL PRODUCTS, INC.10742020-11-06
10841912106490Sterile Protective Barrier KitPROTEK MEDICAL PRODUCTS, INC.16242020-06-01
10841912106506Sterile Protective Barrier KitPROTEK MEDICAL PRODUCTS, INC.16282020-06-01
10841912106513Sterile Protective Barrier KitPROTEK MEDICAL PRODUCTS, INC.16482020-06-01
10841912106520Sterile Protective Barrier KitPROTEK MEDICAL PRODUCTS, INC.16962020-06-01
00850015378331Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E65952020-04-21
00850015378355Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E67092020-04-21
00850015378386Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E67102020-04-21
00850015378416Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E67112020-04-21
00850015378447Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E67122020-04-21
00850015378478Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E67132020-04-21
00850015378591Exact Medical Manufacturing IncEXACT MEDICAL MANUFACTURING, INC.E65982020-04-21
00850024023666Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E5450N2021-04-30
00850024023680Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E5301N2021-04-30
00850024023703Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E5451N2021-04-30
00860003700839Hays Inc.HAYS, INC.HS1500AS2020-06-02
01618125139896TIDIShieldTIDI PRODUCTS, LLC54232016-10-11
01618125139933TIDIShieldTIDI PRODUCTS, LLCCFI-7042016-10-11
01618125140021TIDIShieldTIDI PRODUCTS, LLC54022016-10-11
01618125140038TIDIShieldTIDI PRODUCTS, LLC54032016-10-11
01618125140052TIDIShieldTIDI PRODUCTS, LLC54112016-10-11
01618125140069TIDIShieldTIDI PRODUCTS, LLC54122016-10-11
01618125140076TIDIShieldTIDI PRODUCTS, LLC54142016-10-11
01618125140106TIDIShieldTIDI PRODUCTS, LLC54292016-10-11
01618125140120TIDIShieldTIDI PRODUCTS, LLC54342016-10-11
01618125140182TIDIShieldTIDI PRODUCTS, LLC55652016-10-11
01618125140212Sterile-ZTIDI PRODUCTS, LLC55742016-10-12
01618125140243TIDIShieldTIDI PRODUCTS, LLC90242016-10-11
01618125140328TIDIShieldTIDI PRODUCTS, LLCCFI-6002016-10-11
01618125140359TIDIShieldTIDI PRODUCTS, LLCCFI-60302016-10-11
01618125140403TIDIShieldTIDI PRODUCTS, LLCCFI-6542016-10-11
01618125140427TIDIShieldTIDI PRODUCTS, LLCCFI-6552016-10-11
01618125140441TIDIShieldTIDI PRODUCTS, LLCCFI-6612016-10-11
01618125140472TIDIShieldTIDI PRODUCTS, LLCCFI-6682016-10-11
01618125140601TIDIShieldTIDI PRODUCTS, LLCCFI-7052016-10-11
01618125140656TIDIShieldTIDI PRODUCTS, LLCCFI-7332016-10-11
01618125140830TIDIShieldTIDI PRODUCTS, LLCCFI-9592016-10-11
01618125141059TIDIShieldTIDI PRODUCTS, LLC268042016-10-11
01618125141264TIDIShieldTIDI PRODUCTS, LLCCFI-6572016-10-11