HEALON DUET PRO 10240016

GUDID 05050474651425

HEALON DUET PRO US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative

• Primary Device ID: 05050474651425
• NIH Device Record Key: bd912908-a49c-43be-b9f2-21ffd2c3216c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALON DUET PRO
• Version Model Number: 10240016
• Catalog Number: 10240016
• Company DUNS: 103021940
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05050474651425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P810031

FDA Product Code

• LZP: AID, SURGICAL, VISCOELASTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-26
• Device Publish Date: 2018-07-16

Devices Manufactured by JOHNSON & JOHNSON SURGICAL VISION, INC.

• 05050474755093 - HEALON ENDOCOAT PRO: 2025-08-28 HEALON ENDOCOAT PRO 0,85 ML USA
• 05050474755116 - HEALON DUET PRO II: 2025-08-28 HEALON DUET PRO II US
• 05050474829572 - SMARTLOAD: 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 5.0D
• 05050474829589 - SMARTLOAD: 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 5.5D
• 05050474829596 - SMARTLOAD: 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 6.0D
• 05050474829602 - SMARTLOAD: 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 6.5D
• 05050474829619 - SMARTLOAD: 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 7.0D
• 05050474829626 - SMARTLOAD: 2025-05-21 SMARTLOAD TECNIS EYHANCE US IOL 7.5D