FDA.reportPublic FDA data

MorTan

Primary DI
B090MT20000
Brand
MorTan
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
MT2000
Device description
The Morgan medi-FLOW Lens
Published
2025-06-25
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
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090MT20001PackageHIBCC12In Commercial Distribution
B090MT20000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye irrigation shield, single-useA device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye (e.g., to flush the cornea and sclera of irritating particulates/chemicals). It is a curved/cup-like device, intended to be placed over the eye surface, with a port to allow entry of the irrigation solution; it may include a length of tubing. It is intended to be connected to an irrigation solution reservoir/pump. This is a single-use device.

Regulatory Flags#

DUNS number
017535668
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
B090C140900XO Cross 14C14-090C14-0902022-06-20
B090C14090H0XO Cross 14C14-090-HC14-090-H2022-06-21
B090C141350XO Cross 14C14-135C14-1352022-06-20
B090C14135H0XO Cross 14C14-135-HC14-135-H2022-06-20
B090C141750XO Cross 14C14-175C14-1752022-06-20
B090C14175H0XO Cross 14C14-175-HC14-175-H2022-06-21
B090C35090H0XO Cross 35C35-090-HC35-090-H2022-10-24
B090C351350XO Cross 35C35-135C35-1352022-06-20
B090C35135H0XO Cross 35C35-135-HC35-135-H2022-10-24
B090C35175H0XO Cross 35C35-175-HC35-175-H2022-10-24
00853989006002XableCathXC-014-065AXC-014-065A2018-09-24
00853989006019XableCathXC-014-090AXC-014-090A2018-09-24
00853989006026XableCathXC-014-145AXC-014-145A2018-09-24
00853989006033XableCathXC-018-065AXC-018-065A2018-09-24
00853989006040XableCathXC-018-090AXC-018-090A2018-09-24
00853989006057XableCathXC-018-145AXC-018-145A2018-09-24
00853989006064XableCathXC-035-065AXC-035-065A2018-09-24
00853989006071XableCathXC-035-090AXC-035-090A2018-09-24
00853989006088XableCathXC-035-145AXC-035-145A2018-09-24
00853989006095XableCathXC-014-065BXC-014-065B2018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047926204Irrigation HandpieceA1 Medical GmbHKYG2026-05-29
04251047930003Aspiration HandpieceA1 Medical GmbHKYG2026-05-29
00757770636105Bausch + LombBausch & Lomb IncorporatedKYG2026-04-30
B090MT2020MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
G22312647930Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2025-11-05
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
08052276027290Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2025-06-04
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
00194613022938MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613022945MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023959MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023973MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044817MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044824MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613046101MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060091MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060633MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613088057MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613090340MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
G223IAT3S450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-05-23
08052276026354Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08052276026361Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08052276026378Passive Reservoir AKTIVE SRLKYG2024-01-11
08052276026385Active ReservoirAKTIVE SRLKYG2024-01-11