Device
15-415 Series 5mL OptiDropper®, Bottle White Boston Round
Manufacturer
MPS Pharma & Medical, Inc.
MPS Pharma & Medical, Inc.
Model: UA15-415-10-BOT-5-WHT
DI: 00810080612556
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
15-415 Series 5mL OptiDropper®, Bottle White Boston Round
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
892657f8-6490-41f9-84dd-8b4fa8b29640
Distribution Status:
In Commercial Distribution
DUNS Number:
117970217
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
00810080612556
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Case
Item #2 - Device ID:
10810080612553
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
100
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00810080612556
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61338
Name: Eye dropper bottle
Definition:
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.
FDA Product Codes
KYX
Dispenser, Liquid Medication