SuperEagle 3131J

GUDID 00841668114971

SuperEagle Punctum Plug, Medium, 0.6mm-0.8mm - Twin Pack

KATENA PRODUCTS, INC.

Lacrimal punctum plug

• Primary Device ID: 00841668114971
• NIH Device Record Key: 5edbb237-0d33-4d65-971e-795c19d461d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperEagle
• Version Model Number: 3131J
• Catalog Number: 3131J
• 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	00841668114971 [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 [SuperEagle]

• 00841668114988: SuperEagle Punctum Plug, Large, 0.8mm and larger - Twin Pack
• 00841668114971: SuperEagle Punctum Plug, Medium, 0.6mm-0.8mm - Twin Pack
• 00841668114964: SuperEagle Punctum Plug, Small, 0.4mm-0.6mm - Twin Pack
• 00841668114421: SuperEagle Punctum Plug, Large, 0.8mm and larger - 2 per box
• 00841668114414: SuperEagle Punctum Plug, Medium, 0.6mm-0.8mm - 2 per box
• 00841668114407: SuperEagle Punctum Plug, Small, 0.4mm-0.6mm -2 per box