HEALON ULTIMATE DUAL PACK 10290060

GUDID 00385445402214

DP HEALON 0.55 ML+HEALON5 0.6 ML US

JOHNSON & JOHNSON SURGICAL VISION, INC.

Vitreous/aqueous humour replacement medium, intraoperative

• Primary Device ID: 00385445402214
• NIH Device Record Key: abcbad50-16e8-4a85-ad40-a6cc126918d4
• Commercial Distribution Discontinuation: 2017-11-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HEALON ULTIMATE DUAL PACK
• Version Model Number: 10290060
• Catalog Number: 10290060
• 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: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
• Phone: +1(877)266-4543
• Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.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	00385445402214 [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: 3
• Public Version Date: 2020-02-26
• Device Publish Date: 2014-11-14

Devices Manufactured by JOHNSON & JOHNSON SURGICAL VISION, INC.

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• 05050474812888 - TECNIS ODYSSEY TORIC II IOL: 2024-02-01 TEC ODYSSEY TOR II SMPCY 08.0D CYL3.75
• 05050474811058 - TECNIS ODYSSEY TORIC II IOL: 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.0D CYL1.50
• 05050474811065 - TECNIS ODYSSEY TORIC II IOL: 2024-01-29 TEC ODYSSEY TOR II SMPCY 05.5D CYL1.50