HONAN BALLOON WITH PRESS VALVE K 9-8410

GUDID 00841668112137

KATENA PRODUCTS, INC.

Intraocular pressure-reducing system

• Primary Device ID: 00841668112137
• NIH Device Record Key: d46c77ef-4b85-420c-b040-acc45c83ab64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HONAN BALLOON WITH PRESS VALVE
• Version Model Number: K 9-8410
• Catalog Number: K 9-8410
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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	00841668112137 [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

Devices Manufactured by KATENA PRODUCTS, INC.

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• 00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror: 2024-04-19
• 00841668137406 - VRTIS KUSAKA 25 GAUGE VERTICAL SCISSORS: 2023-10-18 VRTIS KUSAKA 25 GAUGE VERTICAL SCISSORS
• 00841668137413 - VRTIS SATO HORIZONTAL 23 GAUGE SCISSORS: 2023-10-18 VRTIS SATO HORIZONTAL 23 GAUGE SCISSORS
• 10841668114848 - Color Bar Schirmer Tear Test: 2023-07-14 (50 Pouches)
• 10841668143312 - ABS CLEAR CORNEA ANGLED BLADE 2MM 6/BOX: 2023-06-02 ABS CLEAR CORNEA ANGLED BLADE 2MM 6/BOX
• 00841668123966 - Ophthalmic Knife: 2022-12-15 NANO Engineered Diamond Knife 45 degrees
• 00841668123980 - Ophthalmic Knife: 2022-12-15 NANO Engineered Dia Knife 1mm spear ang