Primary Lens Set, 28D, 90D, 4 Mirror

GUDID 00841668144275

KATENA PRODUCTS, INC.

Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens Ophthalmic diagnostic condensing lens

• Primary Device ID: 00841668144275
• NIH Device Record Key: ad0732cd-6c69-46aa-ab13-cc8f03b13140
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primary Lens Set, 28D, 90D, 4 Mirror
• Version Model Number: K31-3005
• Company DUNS: 085668598
• Company Name: KATENA PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668144275 [Primary]

FDA Product Code

• HJL: Lens, condensing, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-19
• Device Publish Date: 2024-04-11

Devices Manufactured by KATENA PRODUCTS, INC.

• 00841668144268 - Primary Lens Set, 28D, 90D, 3 Mirror: 2024-04-19
• 00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror: 2024-04-19
• 00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror: 2024-04-19
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• 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