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

Devices Manufactured by KATENA PRODUCTS, INC.

• 00841668145906 - BLINK: 2026-03-31 Anterior Chamber Cannula - 30G30G x 7/8", (0.3 x 22mm), 4mm Tip
• 00841668145913 - BLINK: 2026-03-31 Anterior Chamber Cannula - 27G27G x 7/8", (0.4 x 22mm), 4mm Tip
• 00841668145920 - BLINK: 2026-03-31 Anterior Chamber Cannula - 21G21G x 7/8", (0.81 x 22mm), 4mm Tip
• 00841668145937 - BLINK: 2026-03-31 Anterior Chamber Cannula - 27G27G x 7/8", (0.4 x 22mm), 6mm Tip
• 00841668145944 - BLINK: 2026-03-31 Anterior Chamber Cannula - 30G30G x 7/8", (0.3 x 22mm) 6mm Tip
• 00841668145951 - BLINK: 2026-03-31 Hydrodissector Cannula - 30G30G x 7/8", (0.3 x 22mm), Angled
• 00841668145968 - BLINK: 2026-03-31 Irrigating Cystotome - 23G23G x 5/8", (0.64 x 16mm), Formed
• 00841668145982 - BLINK: 2026-03-31 Irrigating Cystotome - 25G25G x 5/8", (0.5 x 16mm), Formed