FDA.reportPublic FDA data

AutoDrop

Primary DI
00384706000015
Brand
AutoDrop
Company
OWEN MUMFORD USA INCORPORATED
Model
OP 6000
Device description
AutoDrop Eye Guide
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KCMDropper, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCMDropper, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384706000022PackageGS120In Commercial Distribution
00384706000039PackageGS110In Commercial Distribution
00384706000015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384706000022003847060000223847060000220384706000022
00384706000039003847060000393847060000390384706000039
00384706000015003847060000153847060000150384706000015

GMDN Terms#

Term, Definition table
TermDefinition
Eye dropper bottle aidA non-sterile device intended to be attached to an eye dropper bottle to assist with the self-administration of an eye irrigation/treatment solution. It is typically a plastic device intended to assist with positioning of the nozzle, focusing of the eye, and/or squeezing of the bottle. This is a reusable device.

Regulatory Flags#

DUNS number
803401454
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384701604010Unistik Pro PlusAT 16042025-09-16
00384703160019EmpelvicSM 31602025-08-22
00384703150010EmpelvicSM 31502025-08-22
00384703155015EmpelvicSM 31552025-08-22
00761059640004Unifine OTCAN 36402025-02-14
00761059641001Unifine OTCAN 36412025-02-14
00761059650003Unifine OTCAN 36502025-02-14
00761059651000Unifine OTCAN 36512025-02-14
00761059640028Unifine OTCAN 36402025-02-14
00761059641032Unifine OTCAN 36412025-02-14
00761059650027Unifine OTCAN 36502025-02-14
00761059651031Unifine OTCAN 36512025-02-14
00761059507093Unifine PentipsAN 3550AC2024-05-17
00761059359012Unifine PentipsAN 3590AC2024-02-21
00761059354000Unifine PentipsAN 3540AC2024-02-05
00761059354024Unifine PentipsAN 3540AC2024-02-05
00761059352914Unifine PentipsAN 3529AC2024-01-22
00761059352921Unifine PentipsAN 3529AC2024-01-22
00384707001011Unistik VacuFlipBC 70012023-10-06
00384707102015Unistik VacuFlipBC 71022023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00384706050010AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706150017AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706000022AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00384706100012AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00076855100059ApexDrive Devilbiss HealthcareKCM2023-03-10
00635515992641ApexDrive Devilbiss HealthcareKCM2023-03-10
30076855100050ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
30635515992642ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
00635515992665ApexDrive Devilbiss HealthcareKCM2023-02-15
30041520876479ApexCOMPASS HEALTH BRANDS CORP.KCM2023-02-15
00076855005088ApexDrive Devilbiss HealthcareKCM2023-01-08
00076855700051ApexDrive Devilbiss HealthcareKCM2023-01-08
00076855700075ApexDrive Devilbiss HealthcareKCM2023-01-08
30076855700076ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855700052ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855005089ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
00076855601051ApexDrive Devilbiss HealthcareKCM2022-12-12
00076855605059ApexDrive Devilbiss HealthcareKCM2022-12-12
30076855601052ApexCOMPASS HEALTH BRANDS CORP.KCM2022-12-12
30076855605050ApexCOMPASS HEALTH BRANDS CORP.KCM2022-12-12
00385640005524INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005838INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005883INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005937INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005982INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640006033INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640013437INSTRUSAFESummit Medical, Inc.KCM2021-05-18
00385640005531INSTRUSAFESummit Medical, Inc.KCM2017-11-10