Belotero Balance Lidocaine

GUDID 07640123793316

Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

Dermal tissue reconstructive material, microbe-derived

• Primary Device ID: 07640123793316
• NIH Device Record Key: 2aaf413a-4f11-465b-8446-163182e85f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Belotero Balance Lidocaine
• Version Model Number: 8718M0S
• 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: true
• 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: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com
• Phone: 1-844-469-6379
• Email: mymerzsolutions@merz.com

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640123793316 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-11
• Device Publish Date: 2025-09-30

On-Brand Devices [Belotero Balance Lidocaine]

• 07640123793316: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
• 07640123793309: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i