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 is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
GUDID devices
2,505
Last updated
2024-07-22 06:47:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
16975085709487Cyber SurgeryEXACT MEDICAL MANUFACTURING, INC.CS10002024-07-12
16975085709494Cyber SurgeryEXACT MEDICAL MANUFACTURING, INC.CS10012024-07-12
10380650003888ALCONAlcon Laboratories, Inc.003806500038812024-07-02
16975424195551OSIS MedicalEXACT MEDICAL MANUFACTURING, INC.OS80336502024-06-26
16975424195568OSIS MedicalEXACT MEDICAL MANUFACTURING, INC.OS80336512024-06-26
16975424195575OSIS MedicalEXACT MEDICAL MANUFACTURING, INC.OS80336522024-06-26
26975424195541OSIS MedicalEXACT MEDICAL MANUFACTURING, INC.OS1000HC2024-06-26
30810087350360CoulmedCoulmed Products Group LLCDI-41012023-01-06
30810087350377CoulmedCoulmed Products Group LLCDI-71012023-01-06
30810087350384CoulmedCoulmed Products Group LLCDI-14042023-01-06
30810087350391CoulmedCoulmed Products Group LLCDI-14052023-01-06
30810087350407CoulmedCoulmed Products Group LLCDI-1405-8B2023-01-06
30810087350414CoulmedCoulmed Products Group LLCDI-14062023-01-06
30810087350421CoulmedCoulmed Products Group LLCDI-1406-8B2023-01-06
30810087350438CoulmedCoulmed Products Group LLCDI-14142023-01-06
30810087350445CoulmedCoulmed Products Group LLCDI-14152023-01-06
30810087350452CoulmedCoulmed Products Group LLCDI-14162023-01-06
30810087350469CoulmedCoulmed Products Group LLCDI-14202023-01-06
30810087350476CoulmedCoulmed Products Group LLCDI-14302023-01-06
00850043542049Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518462024-06-11
10850043542008Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518422024-06-11
10850043542015Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518432024-06-11
10850043542022Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518442024-06-11
10850043542039Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518452024-06-11
10850043542053Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518472024-06-11
10850043542060Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518482024-06-11
10850043542077Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518492024-06-11
10850043542084Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518502024-06-11
10850043542091Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518512024-06-11
10850043542107Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518522024-06-11
10850043542114Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518532024-06-11
10850043542121Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518542024-06-11
10850043542138Northfield Medical Manufacturing Northfield Medical Manufacturing, LLC518552024-06-11
10850043542145Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518562024-06-11
10850043542152Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518572024-06-11
10850043542169Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518582024-06-11
10850043542176Northfield Medical ManufacturingNorthfield Medical Manufacturing, LLC518592024-06-11
10685404003436Sterling Medical ProductsAPOLLO MEDICAL PRODUCTS CORP.DR-012024-06-07
16975424192895Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E6792 2024-06-07
04260462740371Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mmPemax Kunststoff GmbH12741.123642024-06-05
04260462740951HMD cover set, consisting of 2 lens protective caps made of PP, color whitePemax Kunststoff GmbH12741.123652024-06-05
04260462741255PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oranPemax Kunststoff GmbHPC2-SD-32024-06-05
04260462742184Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mmPemax Kunststoff GmbH12741.138732024-06-05
04260462742429PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-SCSA-3 Pemax Kunststoff GmbHPC3-SCSA-32024-06-05
04260462742481PEMIDrape - C-arm sterile cover, metal temple cover blue line, Art.Nr. SP-CS-SD-Pemax Kunststoff GmbHSP-CS-SD-32024-06-05
04260462742542PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CAPemax Kunststoff GmbHSP-CA-32024-06-05
04260462743020PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-VB10-3Pemax Kunststoff GmbHPC3-VB10-32024-06-05
04260462743051Sterile Cover for Remote Control Unit Drape Set "VB10-RC"Pemax Kunststoff GmbHVB10-RC2024-06-05
04260462743129Smart Control Sterile Cover for Remote Control VB10 "VB10-SC"Pemax Kunststoff GmbHVB10-SC2024-06-05
16975085705762Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E67182024-06-04
16975085705823Exact Medical Manufacturing, Inc EXACT MEDICAL MANUFACTURING, INC.E67422024-06-04
16975424192581Exact MedicalEXACT MEDICAL MANUFACTURING, INC.DRP-4002024-06-04
16975424194813Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.525-6002024-06-04
16975424194820Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E6867 2024-06-04
06975085701682Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.E54592024-06-03
06975085702108Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.E5411 2024-06-03
16975085701917Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E54312024-06-03
16975085702297Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E53092024-06-03
16975085705359Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E65042024-06-03
16975085705939Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E68252024-06-03
16975085705946Exact MedicalEXACT MEDICAL MANUFACTURING, INC.DRP-302A2024-06-03
16975085705977Exact MedicalEXACT MEDICAL MANUFACTURING, INC.DRP-2012024-06-03
16975085706271Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E65302024-06-03
16975424193915Exact MedicalEXACT MEDICAL MANUFACTURING, INC.102001012024-06-03
07649988629310OdneCleanMinitube ABA-00062024-06-01
00810075281415BoneFoamBONE FOAM, INC.925.HIPPY-DBC-BX202024-05-22
00810339030100SAFE DENTBGSS Company Inc.P50192024-05-15
00810339031398SAFE DENTBGSS Company Inc.H501392024-05-15
00810339031657SAFE DENTBGSS Company Inc.H501382024-05-15
00854014003645SAFE DENTBGSS Company Inc.PT8112W2024-05-15
00854014003683SAFE DENTBGSS Company Inc.PT8113BL2024-05-15
00854014003720SAFE DENTBGSS Company Inc.PT8114DR2024-05-15
00854014003751SAFE DENTBGSS Company Inc.PT8115LV2024-05-15
00854014003812SAFE DENTBGSS Company Inc.PT8117MG2024-05-15
40616258024866Display Control Unit SheathBayer Medical Care Inc.AVA 500 DCOV2024-05-06
40616258024903Avanta Hand Controller SheathBayer Medical Care Inc.AVA 500 HCS2024-05-06
16975424195391Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.E68502024-05-06
00810339030018SAFE DENTBGSS Company Inc.P50132024-05-01
00810339030049SAFE DENTBGSS Company Inc.P5016XL2024-05-01
00810339030070SAFE DENTBGSS Company Inc.P50102024-05-01