Biolon 62501

GUDID 15060156070380

Viscoelastic surgical aid

ALTACOR LIMITED

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: 15060156070380
• NIH Device Record Key: 96541455-637c-416e-b750-b0949f2fbf6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolon
• Version Model Number: version 1
• Catalog Number: 62501
• Company DUNS: 346153906
• Company Name: ALTACOR LIMITED
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401182210150
• Email: pv@altacor-pharma.com
• Phone: +4401182210150
• Email: pv@altacor-pharma.com
• Phone: +4401182210150
• Email: pv@altacor-pharma.com
• Phone: +4401182210150
• Email: pv@altacor-pharma.com
• Phone: +4401182210150
• Email: pv@altacor-pharma.com
• Phone: +4401182210150
• Email: pv@altacor-pharma.com
• Phone: +4401182210150
• Email: pv@altacor-pharma.com

Device Dimensions

• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0
• Total Volume: 1 Milliliter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060156070373 [Primary]
GS1	15060156070380 [Package]; Contains: 15060156070373; Package: case [185 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960011

FDA Product Code

• LZP: AID, SURGICAL, VISCOELASTIC

Sterilization

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

[15060156070380]

Ethylene Oxide

[15060156070380]

Ethylene Oxide

[15060156070380]

Ethylene Oxide

[15060156070380]

Ethylene Oxide

[15060156070380]

Ethylene Oxide

[15060156070380]

Ethylene Oxide

[15060156070380]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-15
• Device Publish Date: 2022-06-07