Belotero Balance
GUDID M2138700M05
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.
MERZ NORTH AMERICA, INC.
Dermal tissue reconstructive material, microbe-derived| Primary Device ID | M2138700M05 |
| NIH Device Record Key | 221b8014-732d-4e1b-ae65-00c7bc0ded7d |
| Commercial Distribution Discontinuation | 2019-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Belotero Balance |
| Version Model Number | 8700M0 |
| Company DUNS | 028147846 |
| Company Name | MERZ NORTH AMERICA, INC. |
| 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 | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com | |
| Phone | 866-862-1211 |
| info@merz.com |
Device Dimensions
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M2138700M05 [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 | 4 |
| Public Version Date | 2023-09-15 |
| Device Publish Date | 2014-09-17 |
Devices Manufactured by MERZ NORTH AMERICA, INC.
| 10810235030638 - Rigid Needle 21 GA x 0.5" (0,8 x 13 mm) | 2024-10-29 |
| 10810235030645 - Coaptite | 2024-10-23 The Coaptite Injectable implant is a permanently implanted device to treat women who have severe stress urinary incontinence due |
| M2138700M05 - Belotero Balance | 2023-09-15Belotero 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. |
| M2138700M05 - Belotero Balance | 2023-09-15 Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of m |
| 08714729804796 - Coaptite | 2022-01-19 The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinenc |
| 00186295000342 - DeScribe Transparent PFD Patch | 2018-03-29 Individually packaged DeScribe PFD Patch (each) Contains 5 DeScribe PFD Patches. |
| 00186295000359 - DeScribe Transparent PFD Patch | 2018-03-29 Individually packaged DeScribe PFD Patch (each) |
| 00186295000366 - DeScribe Transparent PFD Patch | 2018-03-29 Individually packaged DeScribe PFD Patch (each). Contains 2 Describe PFD Patches. |
Trademark Results [Belotero Balance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BELOTERO BALANCE 77751267 3902569 Live/Registered |
MERZ PHARMA GmbH & CO. KGaA 2009-06-03 |
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