EaglePlug 1 3001J

GUDID 00841668114957

Plug 1 Punctum Plug, Fits 0.5mm - 0.8mm D - Twin Pack

KATENA PRODUCTS, INC.

Lacrimal punctum plug

• Primary Device ID: 00841668114957
• NIH Device Record Key: 9573af45-4034-434d-bb24-d075f45ec6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EaglePlug 1
• Version Model Number: 3001J
• Catalog Number: 3001J
• Company DUNS: 085668598
• Company Name: KATENA PRODUCTS, INC.
• Device Count: 1
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668114957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991130

FDA Product Code

• LZU: Plug, Punctum

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: 2017-03-31

On-Brand Devices [EaglePlug 1]

• 00841668114957: Plug 1 Punctum Plug, Fits 0.5mm - 0.8mm D - Twin Pack
• 00841668114391: Plug 1 Punctum Plug, Fits 0.5mm - 0.8mm D - 2 per Box