FDA.reportPublic FDA data

Image Cover 36R

Primary DI
00836230004002
Brand
Image Cover 36R
Company
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
Model
5002
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
01836230004001PackageGS115In Commercial Distribution
02836230004000PackageGS14In Commercial Distribution
00836230004002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01836230004001018362300040011836230004001
02836230004000028362300040002836230004000
00836230004002008362300040028362300040020836230004002

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.

Sterilization Methods#

Method table
Method

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700712438487Maquet OrchideMAQUET SASKQM2026-09-18
03700712438494Maquet OrchideMAQUET SASKQM2026-09-18
10197344213627MEDLINEMEDLINE INDUSTRIES, INC.KQM2026-07-20
00819761023117Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
00819761023124Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
04995047074885CuratOREIZO CORPORATIONKQM2026-06-24
00819761023063Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023087Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
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
05415334001336BARCOBarco NVKQM2024-05-30
04251303302254CuratOREIZO GmbHKQM2024-02-08
14714127861392AESCULAPAesculap AGKQM2023-11-05
06973786290139lmaging Processor System (lncluding Light Source)Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)KQM2023-07-26