FDA.reportPublic FDA data

zumax

Primary DI
06945095528791
Brand
zumax
Company
Zumax Medical Co., LTD
Model
OMS3500
Catalog number
820111-10137-000
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSOMicroscope, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095528791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095528791069450955287916945095528791

Regulatory Flags#

DUNS number
421348837
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095525516zumaxOMS3000 Pro227V3850-002026-11-04
06945095528722zumaxOMS2380820110-10241-0002026-11-04
06945095528739zumaxOMS6000820110-10240-0002026-11-04
06945095528746zumaxOMS3500820111-10136-0002026-11-04
06945095528753zumaxOMS2350820110-10248-0002026-11-04
06945095528760zumaxOMS2350820110-10250-0002026-11-04
06945095528777zumaxOMS2350820110-10249-0002026-11-04
06945095528784zumaxOMS2350820110-10251-0002026-11-04
06945095528807zumaxOMS2350820110-10252-0002026-11-04
06945095528814zumaxOMS2680820112-10104-0002026-11-04
06945095528821zumaxOMS2680820112-10103-0002026-11-04
06945095528838zumaxOMS2000250V0741-R52026-11-04
06945095528852zumaxOMS3200820110-10254-0002026-11-04
06945095529019zumaxOMS2380820110-10268-0002026-11-04
06945095529026zumaxOMS3200820110-10269-0002026-11-04
06945095529033zumaxOMS3200323V2862-292026-11-04
06945095529040zumaxOMS1800258V074N-002026-11-04
06945095529057zumaxOMS3200820110-10272-0002026-11-04
06945095529064zumaxOMS2350820110-10273-0002026-11-04
06945095529071zumaxOMS2000820110-10274-00E2026-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095525516zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528722zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528739zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528746zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528753zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528760zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528777zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528784zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528807zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528838zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528852zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529019zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529026zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529033zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529040zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529057zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529064zumaxZumax Medical Co., LTDFSO2026-11-04
06945095529071zumaxZumax Medical Co., LTDFSO2026-11-04
06945095528944zumaxZumax Medical Co., LTDFSO2026-10-10
06945095528951zumaxZumax Medical Co., LTDFSO2026-10-10
06945095528968zumaxZumax Medical Co., LTDFSO2026-10-10
06945095528869zumaxZumax Medical Co., LTDFSO2026-10-09
06945095528920zumaxZumax Medical Co., LTDFSO2026-10-09
06945095528937zumaxZumax Medical Co., LTDFSO2026-10-09
06945095528975zumaxZumax Medical Co., LTDFSO2026-09-29
06945095528982zumaxZumax Medical Co., LTDFSO2026-09-29
06945095529002zumaxZumax Medical Co., LTDFSO2026-09-29
08906168451499Prima Lite Surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451505Prima Lite Surgical Microscope Wall mountLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451512Prima Lite ENT Surgical MicroscopesLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19