HEALON 10295210

GUDID 00385445085813

HEALON 0.55 ML US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative

• Primary Device ID: 00385445085813
• NIH Device Record Key: 90cbf688-917d-4bbd-ab49-ad8b26c044cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALON
• Version Model Number: 10295210
• Catalog Number: 10295210
• Company DUNS: 103021940
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Device Count: 1
• DM Exempt: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385445085813 [Primary]

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: 4
• Public Version Date: 2020-02-26
• Device Publish Date: 2014-11-14

On-Brand Devices [HEALON]

• 00385445085813: HEALON 0.55 ML US
• 00385445084212: HEALON 0.85 ML US
• 00385445083819: HEALON 0.40 ML US