FDA.reportPublic FDA data

OLYMPUS DRAPE 115X260 5.8 HLT

Primary DI
00836230000301
Brand
OLYMPUS DRAPE 115X260 5.8 HLT
Company
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
Model
8560H
Device description
Medical equipment handle cover, single-use, sterile
Published
2022-11-15
Public version status
New
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
01836230000300PackageGS15In Commercial Distribution
02836230000309PackageGS14In Commercial Distribution
00836230000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01836230000300018362300003001836230000300
02836230000309028362300003092836230000309
00836230000301008362300003018362300003010836230000301

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, single-useA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. 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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06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2025-02-28
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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