DuraPlug 0078

GUDID 00841668114773

DuraPlug 0.4mm D x 2.0mm L - 2/Pkg, 10 Pkg/Box

KATENA PRODUCTS, INC.

Lacrimal punctum plug

• Primary Device ID: 00841668114773
• NIH Device Record Key: c16c7cb2-d122-4579-ad3e-68b0549ecfe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraPlug
• Version Model Number: 0078
• Catalog Number: 0078
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668114773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020882

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 [DuraPlug]

• 00841668114773: DuraPlug 0.4mm D x 2.0mm L - 2/Pkg, 10 Pkg/Box
• 00841668114766: DuraPlug 0.3mm D x 2.0mm L - 2/Pkg, 10 Pkg/Box
• 00841668114759: DuraPlug 0.2mm D x 2.0mm L - 2/Pkg, 10 Pkg/Box