AutoDrop

Basic Information

• Brand Name: AutoDrop
• Primary DI: 00384706000015
• Version / Model: OP 6000
• Company Name: OWEN MUMFORD USA INCORPORATED
• Labeler DUNS: 803401454
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-07
• Public Version: 1
• Public Version Date: 2023-06-15
• Public Version Status: New
• Public Device Record Key: f4a6fdb1-2d05-44bd-8166-2306a006a4cb

Device Description

AutoDrop Eye Guide

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCM	Dropper, Ent	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61580	Eye dropper bottle aid	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00384706000022	GS1	Sleeve	20	In Commercial Distribution
Primary	00384706000015	GS1
Package	00384706000039	GS1	Case	10	In Commercial Distribution