Eye-Cept Rewetting Drops

GUDID 00364108411121

Eye-Cept rewetting drops, 20 x 0.5ml

OPTICS LABORATORY, INC.

Eye dropper, single-use

• Primary Device ID: 00364108411121
• NIH Device Record Key: 6528b6d9-bc85-49c8-9f0f-c57c7ee895bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye-Cept Rewetting Drops
• Version Model Number: 411
• Company DUNS: 018503552
• Company Name: OPTICS LABORATORY, INC.
• Device Count: 1
• 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	00364108411121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041008

FDA Product Code

• LPN: Accessories, Soft Lens Products

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-07

Devices Manufactured by OPTICS LABORATORY, INC.

• 00364108422011 - LensGiene: 2023-05-15 Contact lens sterile saline solution
• 00364108411121 - Eye-Cept Rewetting Drops: 2018-07-06Eye-Cept rewetting drops, 20 x 0.5ml
• 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