HONAN BALLOON HEADBAND (NO LATEX) K 9-8412

GUDID 00841668112151

KATENA PRODUCTS, INC.

Intraocular pressure-reducing system

• Primary Device ID: 00841668112151
• NIH Device Record Key: e8c3a956-b621-4616-8a83-a5f2392c461b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HONAN BALLOON HEADBAND (NO LATEX)
• Version Model Number: K 9-8412
• Catalog Number: K 9-8412
• Company DUNS: 085668598
• Company Name: KATENA PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Expiration Date: false
• 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	00841668112151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820526

FDA Product Code

• LCC: Applicator, Ocular Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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