Belotero Balance

GUDID 07640123791213

Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.

ANTEIS SA

Dermal tissue reconstructive material, microbe-derived

• Primary Device ID: 07640123791213
• NIH Device Record Key: 05061181-8070-45c6-bf0e-58480954e17f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Belotero Balance
• Version Model Number: 8700M0S
• Company DUNS: 482133837
• Company Name: ANTEIS SA
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com
• Phone: 888-972-4588
• Email: myMerzSolutions@merz.com

Device Dimensions

• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter
• Needle Gauge: 27 Gauge
• Needle Gauge: 30 Gauge
• Total Volume: 1 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640123791213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P090016

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [Belotero Balance]

• 07640123791121: Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to
• 07640123791213: Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to
• 07640123791152: Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to