FDA UDI
In Commercial Distribution
🇺🇸 United States
SCULPTRA
DI: 08437027710117
·
Model: 2 Vials
·
SAIMA GLOBAL FARMA S.L.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- SCULPTRA
- Primary DI
- 08437027710117
- Version / Model
- 2 Vials
- Company Name
- SAIMA GLOBAL FARMA S.L.
- Labeler DUNS
- 468910220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2026-02-19
- Public Version
- 1
- Public Version Date
- 2026-02-27
- Public Version Status
- New
- Public Device Record Key
- 2dbfc1dd-7aa1-4a12-af65-8e0ddb9e529a
Device Description
SCULPTRA is a sterile, injectable, biocompatible, biodegradable material that is made of poly-L-lactic acid (a synthetic polymer), sodium carboxymethylcellulose and non-pyrogenic mannitol. SCULPTRA is indicated for use in immune-competent subjects for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, and correction of fine lines and wrinkles in the cheek region. It is also indicated in people with HIV-associated lipoatrophy for restoration and/or correction of the signs of facial fat loss.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59133 | Dermal tissue reconstructive material, synthetic mineral | A sterile, bioabsorbable, inorganic chemically synthesized mineral (e.g., synthesized calcium hydroxyapatite) intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it does not include a local anaesthetic agent. The material is typically preloaded in a disposable syringe. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08437027710100 | GS1 | ||||
| Primary | 08437027710117 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030050 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature up to 30°C (86°F)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigeration not required