Sculptra
GUDID 20302995961033
GALDERMA LABORATORIES, L.P.
Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral| Primary Device ID | 20302995961033 |
| NIH Device Record Key | 2b67fc10-501b-4904-8fe0-2557e69a93d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sculptra |
| Version Model Number | Aesthetic - Sample |
| Company DUNS | 047350186 |
| Company Name | GALDERMA LABORATORIES, L.P. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature up to 30°C (86°F) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20302995961033 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P030050
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-10-10 |
On-Brand Devices [Sculptra]
| 20302995961064 | Aesthetic |
| 20302995961057 | HIV - Sample |
| 20302995961040 | HIV |
| 20302995961033 | Aesthetic - Sample |
| 00302995961084 | 1 vial pack |
| 00302995961077 | 2 vial pack |
Trademark Results [Sculptra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCULPTRA 85106833 not registered Dead/Abandoned |
VALEANT INTERNATIONAL BERMUDA 2010-08-13 |
 SCULPTRA 78266887 3056196 Live/Registered |
NESTLÃ SKIN HEALTH S.A. 2003-06-25 |
 SCULPTRA 77042446 not registered Dead/Abandoned |
Aventis Pharmaceuticals Inc. 2006-11-13 |
 SCULPTRA 73001341 0998950 Dead/Expired |
CRANE CO. 1973-09-19 |
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