MD Ophthalmic Dropper Bottles

Basic Information

• Brand Name: MD Ophthalmic Dropper Bottles
• Primary DI: 00338779559543
• Version / Model: 5595-04
• Catalog Number: 5595-04
• Company Name: Medisca Inc.
• Labeler DUNS: 794301960
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-05-12
• Public Version: 1
• Public Version Date: 2023-05-22
• Public Version Status: New
• Public Device Record Key: b72781e8-d7c9-48cc-be8a-1d29d484183c

Device Description

MD Ophthalmic Dropper Bottles, 10 mL, Sterile, Ready-to-fill, White with White Caps

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61338	Eye dropper bottle	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10338779559540	GS1
Primary	00338779559543	GS1