Optisource

GUDID 00817096001565

Classic Flat pack, Yellow 100/bag

PHOENIX HEALTHCARE SOLUTIONS, LLC

Contact lens case

• Primary Device ID: 00817096001565
• NIH Device Record Key: d16f8193-1961-4ee5-8777-80589b20f08b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optisource
• Version Model Number: 74-1050-O
• Company DUNS: 079146847
• Company Name: PHOENIX HEALTHCARE SOLUTIONS, LLC
• Device Count: 100
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817096001565 [Primary]
GS1	10817096001562 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231123

FDA Product Code

• LRX: Case, Contact Lens

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-26
• Device Publish Date: 2024-08-18

On-Brand Devices [Optisource]

• 00817096001572: Classic Flat pack, White 100/bag
• 00817096001565: Classic Flat pack, Yellow 100/bag
• 00817096001558: Classic Flat pack, Green 100/bag
• 00817096001541: Classic Flat pack, Clear 100/bag
• 00817096001534: Classic Flat pack, Blue 100/bag
• 00817096001527: Classic Flat pack, Assorted 100/bag
• 00817096001510: Sunglass-shaped Flat pack, White 100/bag
• 00817096001503: Sunglass-shaped Flat pack, Orange 100/bag
• 00817096001497: Sunglass-shaped Flatpack, Green 100/bag
• 00817096001480: Sunglass-shaped Flatpack, Blue 100/bag
• 00817096001473: Sunglass-shaped Flat pack, Black 100/bag
• 00817096001466: Sunglass-shaped Flat pack, Asst 100/bag
• 00817096001459: Dome-top Flat pack, White 100/bag
• 00817096001442: Dome-top Flat pack, Orange 100/bag
• 00817096001435: Dome-top Flat pack, Green 100/bag
• 00817096001428: Dome-top Flat pack, Clear 100/bag
• 00817096001411: Dome-top Flat pack, Blue 100/bag
• 00817096001404: DOME-TOP FLAT PACK -ASST 100/BAG