HEALON5 PRO 10240015

GUDID 05050474636996

HEALON5 PRO 0.6 ML US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative Vitreous/aqueous humour replacement medium, intraoperative

• Primary Device ID: 05050474636996
• NIH Device Record Key: 34f3de5b-7145-4e99-bdd6-d2348baeee62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALON5 PRO
• Version Model Number: 10240015
• Catalog Number: 10240015
• 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	05050474636996 [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: 2018-06-25

On-Brand Devices [HEALON5 PRO]

• 05050474636996: HEALON5 PRO 0.6 ML US
• 05050474807464: HEALON5 PRO 0,6 ML US