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
4,853
Last updated
2026-10-13 01:13:51

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITL-E64472026-10-01
06975424191068Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.DRP001-102026-09-30
10665973027347DukalDukal LLC276022022-12-06
06975424191044Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.LGS-KIT-02522026-09-29
00680211003306PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCMC-3018-D2026-09-22
00680211003290PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCPC-0824 W/B2026-09-21
06975424191006Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.WM6522026-09-21
10197344220083MEDLINEMEDLINE INDUSTRIES, INC.DYNJP2530TWL2026-09-18
10197344220090MEDLINEMEDLINE INDUSTRIES, INC.DYNJP2540TWL2026-09-18
D784UBC80461UnipackUNIPACK MEDICAL CORPORATIONUBC-80462022-12-06
00616784213620Disposable BP Cuff Barrier Sleeves, Non-Woven, White, UniversalDynarex Corporation21362022-04-23
08055713175035Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.ACC-3002025-04-21
10665973027279DukalDukal LLC276102022-12-06
16931918141121AllesetGRI Medical & Electronic Technology Co., Ltd.MV-13313-S2026-07-28
16931918145204AllesetGRI Medical & Electronic Technology Co., Ltd.MV-13103-S2026-07-28
16931918183800InvenioGRI Medical & Electronic Technology Co., Ltd.MV-13323-S2026-07-28
00724995356699CLEANASCOPESTERIS ITALY SRLSterile Tray Liner System2026-05-26
00724995356705CLEANASCOPESTERIS ITALY SRLSterile Tray Liner System2026-05-26
00724995356712CLEANASCOPE ADVANTAGESTERIS ITALY SRLSterile Tray Liner System2026-05-26
00724995356729CLEANASCOPE ADVANTAGESTERIS ITALY SRLSterile Tray Liner System2026-05-26
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.610-25562026-07-27
10810030863431NAMID CENTRAL MEDICAL CORP.DRP5542023-03-01
10810030863448NAMID CENTRAL MEDICAL CORP.DRP5552023-03-01
10810030863455NAMID CENTRAL MEDICAL CORP.DRP5562023-03-01
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.IVL10CS, IVL1CS2026-07-27
18011517135801CLEANASCOPESTERIS ITALY SRLSterile Tray Liner System2022-09-30
18011517135856CLEANASCOPE AdvantageSTERIS ITALY SRLSterile Tray Liner System2022-09-30
00888867020498Arthrex®ARTHREX, INC.AR-16482018-08-03
50732224003936Non-Woven Headrest coversCROSSTEX INTERNATIONAL, INC.L3CB2022-09-29
00618125155361SteriGearTIDI PRODUCTS, LLC273442022-09-29
08055713175073Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.ACC-3002026-07-20
06975424190771Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.CS10002026-07-16
10665973027354DukalDukal LLC276032022-12-06
06975085709480Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.CS10002024-07-12
00852348007445AerobiotixAEROBIOTIX USA LLCAeroCure Vac Filter Drape2021-10-01
00852348007452AerobiotixAEROBIOTIX USA LLCAeroCure Vac Sterile Filter Drape2022-01-03
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., Ltdcamera drape2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.57056002026-06-25
00842430104947Levó Protective Arm SleeveMIZUHO ORTHOPEDIC SYSTEMS, INC.78922019-03-08
06430035873371OCCLUSAL 4C KIT SCAN EXAMPaloDEx Group Oy900801-DEX2026-06-22
10665973027262DukalDukal LLC276092022-12-06
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCC-ARM 24542026-07-06
00840456214305JMUJMU DENTAL, INC130040052026-07-06
00840456214312JMUJMU DENTAL, INC130040042026-07-06
00840456214329JMUJMU DENTAL, INC130080012026-07-06
00840456214336JMUJMU DENTAL, INC130090022026-07-06
00840456214343JMUJMU DENTAL, INC130100112026-07-06
00840456214350JMUJMU DENTAL, INC130100102026-07-06
00840456214367JMUJMU DENTAL, INC130100092026-07-06
00840456214374JMUJMU DENTAL, INC130120022026-07-06
00840456214381JMUJMU DENTAL, INC130120012026-07-06
00840456214398JMUJMU DENTAL, INC130130022026-07-06
00840456214404JMUJMU DENTAL, INC130130012026-07-06
00840456214411JMUJMU DENTAL, INC130190032026-07-06
00840456214428JMUJMU DENTAL, INC130190022026-07-06
00840456214435JMUJMU DENTAL, INC130190012026-07-06
00840456214442JMUJMU DENTAL, INC130250012026-07-06
00840456215265JMUJMU DENTAL, INC130150012026-07-06
00840456215746JMUJMU DENTAL, INC130190042026-07-06
00840456217184JMUJMU DENTAL, INC130060022026-07-06
00840456220740JMUJMU DENTAL, INC130220022026-07-06
00840456220757JMUJMU DENTAL, INC130220032026-07-06
00840456220764JMUJMU DENTAL, INC130220042026-07-06
00840456220771JMUJMU DENTAL, INC130220052026-07-06
00840456220788JMUJMU DENTAL, INC130220062026-07-06
00748426263448Convertors®Microtek Medical LLCEquipment Drapes2026-06-09
00810075280005BoneFoamBONE FOAM, INC.10-910-002022-05-22
00810075280067BoneFoamBONE FOAM, INC.10-910-032022-05-22
00810075280074BoneFoamBONE FOAM, INC.10-910-06-C2022-05-22
00810075280081BoneFoamBONE FOAM, INC.10-910-01-C2022-05-22
00810075281316BoneFoamBONE FOAM, INC.925.UPS-DBC-BX202022-12-19
30680651424465HalyardO&M HALYARD, INC.42446NS2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLC8187N2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLC8188NC2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLC8189N2026-06-02
50885380097193CONVERTORSCardinal Health 200, LLC8188NC2016-06-21
00748426121861OLYMPUSMicrotek Medical LLCEquipment Drapes2026-05-28
07466532979338Moon SurgicalDAS Medical International SRL3002026-05-28
10665973027248DukalDukal LLC276072022-12-06
00840456201756JMUJMU DENTAL, INC481010012026-05-27