U.S. IOL, Inc.

Basic Information

• Brand Name: U.S. IOL, Inc.
• Primary DI: 00803878044721
• Version / Model: U-BLUE
• Catalog Number: U-BLUE
• Company Name: U.S. IOL, INC.
• Labeler DUNS: 604739490
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: 1d9da62a-77b2-4835-a0a3-618c149014c2

Device Description

U-BLUE Trypan Blue Solution 0.06%

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAR	Suture, nonabsorbable, synthetic, polyamide	General, Plastic Surgery	878.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45180	Ophthalmic surgical dye	A colouring intended to be used to stain tissues/structures in the eye during ophthalmic surgery (e.g., phacoemulsification vitrectomy) to enhance the visibility of specific tissues/structures (e.g., anterior lens capsule, vitreous body) to facilitate the procedure, or used to stain a corneal graft before keratoplasty. It is typically available as a solution (e.g., trypan blue, triamcinolone). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00803878044721	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K024090	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius