Model: 360 mL
DI: 04950055206505
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5f3a7698-0a6e-4874-8e3e-28a04db744cb
Distribution Status:
In Commercial Distribution
DUNS Number:
696350276
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
No
Identifiers
Device ID:
04950055206505
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 48075
Name: Multi-purpose rigid contact lens solution
Definition:
A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting rigid gas permeable (RGP) and hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused.
FDA Product Codes
MRC
Products, Contact Lens Care, Rigid Gas Permeable
Premarket Submissions
Submission Number:
K251876
Supplement Number:
000