Belotero Balance (+) Lidocaine

Basic Information

• Brand Name: Belotero Balance (+) Lidocaine
• Primary DI: 07640123791145
• Version / Model: 8710M0
• Company Name: ANTEIS SA
• Labeler DUNS: 482133837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-01
• Public Version: 1
• Public Version Date: 2023-06-09
• Public Version Status: New
• Public Device Record Key: ed53f6c3-2658-4c22-91c7-fb255fc3b5d5

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMH	Implant, Dermal, For Aesthetic Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47887	Dermal tissue reconstructive material, microbe-derived, anaesthetic	A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640123791145	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	1.0	Milliliter
Needle Gauge	27	Gauge
Needle Gauge	30	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Freeze