Belotero Balance
GUDID 07640123791152
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. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
Dermal tissue reconstructive material, microbe-derived| Primary Device ID | 07640123791152 |
| NIH Device Record Key | 4500c598-1dae-45b5-a7f4-927b5abc6795 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Belotero Balance |
| Version Model Number | 8706M0 |
| 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 | 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 | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| myMerzSolutions@merz.com | |
| Phone | 888-972-4588 |
| 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 |
| 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 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640123791152 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
On-Brand Devices [Belotero Balance]
| 07640123791121 | Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to |
| 07640123791213 | Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to |
| 07640123791152 | Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to |
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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