FDA.reportPublic FDA data

OptiDropper™

Primary DI
00810080612358
Brand
OptiDropper™
Company
MPS Pharma & Medical, Inc.
Model
AC211632-12
Device description
OptiDropper™ 7ML Sterile Dropper Bottle
Published
2025-05-12
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
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810080612355PackageGS1144In Commercial Distribution
00810080612358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081008061235510810080612355
00810080612358008100806123588100806123580810080612358

GMDN Terms#

Term, Definition table
TermDefinition
Eye dropper bottleA sterile device intended to store and dispense in drops an eye irrigation solution typically to flush the eye of irritating particulates/chemicals, or to treat a specific eye condition. It does not contain eye irrigation solution. It consists of a small bottle with a nozzle which acts as a dropper spout. This is a single-use device.

Regulatory Flags#

DUNS number
117970217
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810080612525OptiDropper®, SafeFill™UA15-415-50-TRAY-15CR2026-05-14
00810080612532OptiDropper®, SafeFill™UA15-415-109-TRAY-5-WHT2026-05-14
00810080612549OptiDropper®UA15-415-10-BOT-52026-05-14
00810080612556OptiDropper®UA15-415-10-BOT-5-WHT2026-05-14
00810080612563SAFEFILL™UA15-415-50-TRAY-10-WHT2026-05-14
00810080612518CONNECTOR LUER FEMALE/MALEPLS616082025-11-07
00810080612501OptiDropper®, SafeFill™UA15-415-109-TRAY-52025-10-22
00810080612495OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
10810080612492OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
00810080612488OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
10810080612485OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
00810080612464OptiDropper®UA15-415-108-TRAY-72025-07-19
10810080612461OptiDropper®UA15-415-108-TRAY-72025-07-19
00810080612372OptiDropper™ AC211633-122025-05-13
10810080612379OptiDropper™ AC211633-122025-05-13
00810080612327OptiDropper™AC211631-22025-05-12
00810080612334OptiDropper™ AC211631-3002025-05-12
00810080612341OptiDropper™ AC211632-12025-05-12
00810080612365OptiDropper™AC211633-12025-05-12
00810080612389OptiDropper™AC211633-25R2025-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
09420060205039haakaaTHINK GREEN LIMITEDKYX2026-09-20
09420060205046haakaaTHINK GREEN LIMITEDKYX2026-09-20
10840330702765ProCureTwin Med, LLCKYX2026-07-08
00827989008175Topi-CLICKHealth Care Logistics, Inc.KYX2026-06-15
18859299184705SMARTeZ Fluid Transfer SetEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDKYX2026-04-08
08809692500285Dr.INVIVOROKIT HEALTHCARE Inc.KYX2026-04-02
00008279897857Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2026-01-29
30827989000354Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-09-16
10827989003924Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003931Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003948Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989003955Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2025-01-08
10827989000381Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989000404Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003429Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-08-09
10827989003801Health Care Logistics, Inc®Health Care Logistics, Inc.KYX2024-05-20