FDA.reportPublic FDA data

Microscope Cover ZEISS "MD" 115/260 6.50

Primary DI
01836230000126
Brand
Microscope Cover ZEISS "MD" 115/260 6.50
Company
PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
Model
8276
Device description
Medical equipment drape, single-use
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01836230000126PackageGS15In Commercial Distribution
02836230000125PackageGS14In Commercial Distribution
00836230000127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01836230000126018362300001261836230000126
02836230000125028362300001252836230000125
00836230000127008362300001278362300001270836230000127

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532186541
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06945095528814zumaxZumax Medical Co., LTDHRM2026-11-04
06945095528821zumaxZumax Medical Co., LTDHRM2026-11-04
04547451025580INAMIINAMI & CO., LTD.HRM2026-10-30
06945095535904zumaxZumax Medical Co., LTDHRM2026-10-10
06945095535928zumaxZumax Medical Co., LTDHRM2026-10-10
04547451338697INAMIINAMI & CO., LTD.HRM2026-10-01
04064434000209Heidelberg OPERAMunich Surgical Imaging GmbHHRM2026-05-14
00380650008374UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008381UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008398UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008404UNITYAlcon Laboratories, Inc.HRM2026-04-09
04049584037909Cable SDI BIOM 6 for Alcon LuxOR RevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
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04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLumaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037695Focusing Module BIOM 6, 175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037701Focusing Module BIOM 6, 200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037718Precision Mount for B&LOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037725Precision Mount for LeicaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037732Precision Mount for AlconOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037749Precision Mount for ZeissOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037756Precision Mount for Haag StreitOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037152BIOM 6OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-14
00454745102558INAMIINAMI & CO., LTD.HRM2025-11-12
04547451081777INAMIINAMI & CO., LTD.HRM2025-11-12
07630802403711PROVEO 8xLeica Microsystems (Schweiz) AGHRM2025-10-03
04064434000193SeeLuma Digital Binoculars ModuleMunich Surgical Imaging GmbHHRM2025-08-05
06972039971061MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23