Belotero Balance · 8700M0
MERZ NORTH AMERICA, INC. · Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correc…
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- Labeling does not contain MRI Safety Information
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- Not in Commercial Distribution
- Public device record key
- 221b8014-732d-4e1b-ae65-00c7bc0ded7d
- Has serial number
- false
- Public version date
- 2023-09-15
- Commercial distribution end date
- 2019-12-31
- Is direct marking exempt
- false
- Public version number
- 4
- Labeler duns number
- 028147846
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- 8700M0
- Has manufacturing date
- false
- Brand name
- Belotero Balance
- Is combination product
- false
- Is kit
- true
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Company name
- MERZ NORTH AMERICA, INC.
- Public version status
- Update
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2014-09-17
- Device description
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. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch.
- Storage
- Type
- Special Storage Condition, Specify
- Special conditions
- DO NOT REFRIGERATE
- Type
- Storage Environment Temperature
- High
- Unit
- Degrees Fahrenheit
- Value
- 86
- Low
- Unit
- Degrees Fahrenheit
- Value
- 59
- Sterilization
- Is sterile
- true
- Is sterilization prior use
- false
- Identifiers
- ID
- M2138700M05
- Type
- Primary
- Issuing agency
- HIBCC
- Product codes
- Code
- LMH
- Name
- Implant, Dermal, For Aesthetic Use
- Harmonized identifiers (openFDA)
- Device name
- Implant, Dermal, For Aesthetic Use
- Medical specialty description
- Unknown
- Device class
- 3
- Premarket submissions
- Submission number
- P090016
- Supplement number
- 000
- Customer contacts
- Phone
- 866-862-1211
- info@merz.com
- Gmdn terms
- Code
- 59131
- Name
- Dermal tissue reconstructive material, microbe-derived
- Implantable
- true
- Code status
- Active
- Definition
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 does not include a local anaesthetic agent. 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.
- Device sizes
- Type
- Total Volume
- Value
- 1
- Unit
- Milliliter