Belotero Balance (+) Lidocaine

GUDID 07640123791220

Belotero Balance (+) Lidocaine 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 (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels

ANTEIS SA

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 07640123791220
• NIH Device Record Key: 336d526c-2e56-43bf-b960-2857f4ef4d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Belotero Balance (+) Lidocaine
• Version Model Number: 8705M0S
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640123791220 [Primary]

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: 2021-01-11
• Device Publish Date: 2021-01-01

On-Brand Devices [Belotero Balance (+) Lidocaine ]

• 07640123791220: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
• 07640123791138: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
• 07640123791343: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i
• 07640123791145: Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection i