EaglePlug TearFlow 3008

GUDID 00841668114681

EaglePlug TearFlow, Plug 0.8mm D, Lumen 0.3mm D - 2 per box

KATENA PRODUCTS, INC.

Lacrimal punctum plug

• Primary Device ID: 00841668114681
• NIH Device Record Key: 6715e4cc-fa73-492b-b1e6-bb53e502c10d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EaglePlug TearFlow
• Version Model Number: 3008
• Catalog Number: 3008
• 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

Customer Support Contacts

• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com
• Phone: (973) 989-1600
• Email: globe@katena.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668114681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890920

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 TearFlow]

• 00841668114704: EaglePlug TearFlow, Plug 1.0mm D, Lumen 0.5mm D - 2 per box
• 00841668114698: EaglePlug TearFlow, Plug 0.9mm D, Lumen 0.4mm D - 2 per box
• 00841668114681: EaglePlug TearFlow, Plug 0.8mm D, Lumen 0.3mm D - 2 per box
• 00841668114674: EaglePlug TearFlow, Plug 0.7mm D, Lumen 0.3mm D - 2 per box
• 00841668114667: EaglePlug TearFlow, Plug 0.6mm D, Lumen 0.3mm D - 2 per box
• 00841668114650: EaglePlug TearFlow, Plug 0.5mm D, Lumen 0.2mm D - 2 per box