Sculptra
GUDID 20302995961040
GALDERMA LABORATORIES, L.P.
Dermal tissue reconstructive material, synthetic mineral| Primary Device ID | 20302995961040 |
| NIH Device Record Key | 0cc528b1-7564-4c7e-8ec7-9bb7109de146 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sculptra |
| Version Model Number | HIV |
| 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 | 20302995961040 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.