LensGiene

GUDID 00364108422011

Contact lens sterile saline solution

OPTICS LABORATORY, INC.

Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Contact lens rinsing solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution Rigid contact lens cleaning solution

• Primary Device ID: 00364108422011
• NIH Device Record Key: 8ab2f83e-0b53-4f0a-8ca3-0d6883b4d6f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensGiene
• Version Model Number: KSS02
• Company DUNS: 018503552
• Company Name: OPTICS LABORATORY, INC.
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00364108422011 [Unit of Use]
GS1	00364108422301 [Primary]

FDA Product Code

• MRC: Products, Contact Lens Care, Rigid Gas Permeable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-15
• Device Publish Date: 2023-05-05

Devices Manufactured by OPTICS LABORATORY, INC.

• 00364108422011 - LensGiene: 2023-05-15Contact lens sterile saline solution
• 00364108422011 - LensGiene: 2023-05-15 Contact lens sterile saline solution
• 00364108411121 - Eye-Cept Rewetting Drops: 2018-07-06 Eye-Cept rewetting drops, 20 x 0.5ml
• 00364108431242 - Eye-Cept Sterile Saline Solution: 2018-07-06 10ml single use sterile saline solution for soft contact lens