Eye-Cept Rewetting Drops

Basic Information

• Brand Name: Eye-Cept Rewetting Drops
• Primary DI: 00364108411121
• Version / Model: 411
• Company Name: OPTICS LABORATORY, INC.
• Labeler DUNS: 018503552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-07
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 6528b6d9-bc85-49c8-9f0f-c57c7ee895bb

Device Description

Eye-Cept rewetting drops, 20 x 0.5ml

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPN	Accessories, Soft Lens Products	Ophthalmic	886.5928	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35062	Eye dropper, single-use	A pipette-like device intended to be used for aspirating a small volume of liquid so that it can be dispensed in single drops onto the external surface of the eye. It is typically designed as a hollow tube, with an aspiration bulb attached to the proximal end and a narrowed opening at the distal end. It is usually made of glass or plastic with a rubber teat. It may contain a medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00364108411121	GS1

Premarket Submissions

Submission Number	Supplement Number
K041008	000