Identity
- Trade Name
- Sculptra FDA UDI
- Generic Name
- Dermal tissue reconstructive material, synthetic mineral FDA UDI
- Model / Reference
- Aesthetic - Sample FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20302995961033 FDA UDI
- FDA Product Code
- LMH FDA UDI
- GMDN Term
- Dermal tissue reconstructive material, synthetic mineral FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermal tissue reconstructive material, synthetic mineral
Sculptra by Galderma Laboratories, L.p. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Galderma Laboratories, L.p.
Sources (1)
- FDA UDI 2b67fc10-501b-4904-8fe0-2557e69a93d3 33 fields · synced Jun 8, 2026