Sphere Introducer K8-6000

GUDID 00841668110836

CARTER SPHERE INTRODUCER

KATENA PRODUCTS, INC.

Orbital sphere implant introducer

• Primary Device ID: 00841668110836
• NIH Device Record Key: 293bee3a-b06d-4477-b67d-9cef930fb835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sphere Introducer
• Version Model Number: K8-6000
• Catalog Number: K8-6000
• 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: false
• 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: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: info@katena.com
• Phone: +1(973)989-1600
• Email: inquiries.corzaeye@corza.com
• Phone: +1(973)989-1600
• Email: inquiries.corzaeye@corza.com
• Phone: +1(973)989-1600
• Email: inquiries.corzaeye@corza.com
• Phone: +1(973)989-1600
• Email: inquiries.corzaeye@corza.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841668110836 [Primary]

FDA Product Code

• HNP: Introducer, sphere

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: 2020-09-22
• Device Publish Date: 2020-09-14

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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
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• 00841668123980 - Ophthalmic Knife: 2022-12-15 NANO Engineered Dia Knife 1mm spear ang