FDA.reportPublic FDA data

C-Arm Cover IMAGE INTENSHFIER 115/240

Primary DI
00836230002015
Brand
C-Arm Cover IMAGE INTENSHFIER 115/240
Company
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
Model
4445
Device description
Medical equipment drape, single-use
Published
2022-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01836230002014PackageGS15In Commercial Distribution
02836230002013PackageGS14In Commercial Distribution
00836230002015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01836230002014018362300020141836230002014
02836230002013028362300020132836230002013
00836230002015008362300020158362300020150836230002015

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA 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.

Regulatory Flags#

DUNS number
532186541
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00836230005092Anovo MULTI-PORT STERILE DRAPEFP-04-00202026-03-15
01836230004391Microscope Cover MITAKA 137/380 HLTMU8090HRW2025-06-16
01836230004407Microscope Cover MITAKA mm80, mm90, 80/276MU8190HRSN2025-06-16
02836230004390Microscope Cover MITAKA 137/380 HLTMU8090HRW2025-06-16
02836230004406Microscope Cover MITAKA mm80, mm90, 80/276MU8190HRSN2025-06-16
00836230004392Microscope Cover MITAKA 137/380 HLTMU8090HRW2025-06-16
00836230004408Microscope Cover MITAKA mm80, mm90, 80/276MU8190HRSN2025-06-16
17290115960591Microscope Cover MITAKA mm80, mm90, 80/266MU8090HRSN2025-06-11
27290115960598Microscope Cover MITAKA mm80, mm90, 80/266MU8090HRSN2025-06-11
07290115960594Microscope Cover MITAKA mm80, mm90, 80/266MU8090HRSN2025-06-11
00836230000011"Microscope Cover ZEISS ""MD"" 50/180 6.50"81112022-11-16
00836230000028"Microscope Cover ZEISS ""OPMI"" 115/180 4.85"82142022-11-16
00836230000035Microscope Cover LEICA 115/180 7.0082182022-11-16
00836230000042"Microscope Cover ZEISS ""OPMI"" 50/180 4.85"82222022-11-16
00836230000059"Microscope Cover ZEISS ""OPMI"" 115/260 4.85"82242022-11-16
00836230000066Microscope Cover LEICA 115/260 7.0082282022-11-16
00836230000073Microscope Cover LEICA 115/300 7.0082982022-11-16
00836230000103"Microscope Cover ZEISS ""MD"" 115/180 6.50"82662022-11-16
00836230000127"Microscope Cover ZEISS ""MD"" 115/260 6.50"82762022-11-16
00836230000141Microscope Cover LEICA 115/180 7.0 HLT9218H2022-11-16

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Primary DI, Brand, Company table
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04548736183407SONYSONY CORPORATIONKQM2026-04-30
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00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2024-06-11
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06932503563765eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09