SCULPTRA

Primary DI
08437027710100
Brand
SCULPTRA
Company
SAIMA GLOBAL FARMA S.L.
Model
2 Vials
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.
Published
2026-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LMHImplant, Dermal, For Aesthetic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030050000SCULPTRA AND SCULPTRA AESTHETICQ-Med AB2004-08-03LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437027710117PrimaryGS10
08437027710100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437027710117084370277101178437027710117
08437027710100084370277101008437027710100

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, synthetic mineralA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Refrigeration not required
Special Storage Condition, Specify00Store at room temperature up to 30°C (86°F)

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
468910220
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437027710117SCULPTRA2 Vials2026-02-19
08437027710063RESTYLANE DEFYNEGel 1 mL Syringe2025-06-30
08437027710070RESTYLANE KYSSEGel 1 mL Syringe2025-06-30
08437027710087RESTYLANE LYFT WITH LIDOCAINEGel 1 mL Syringe2025-06-30
08437027710094RESTYLANE REFYNEGel 1 mL Syringe2025-06-30
08437027710001DUROLANE10820202024-11-13
08437027710018MONOVISC2775152024-11-13
08437027710025ORTHOVISC2775002024-11-13
08437027710049SYNVISC ONE58468-0090-32024-11-13
08437027710056SYNVISC58468-0090-12024-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262533320055JuvedermArcera GmbHLMH2026-05-08
04262533320062RestylaneArcera GmbHLMH2026-05-08
07331689120301Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120318Restylane Lyft with LidocaineQ-Med ABLMH2026-04-30
07331689120325Restylane EyelightQ-Med ABLMH2026-04-30
07331689120332Restylane EyelightQ-Med ABLMH2026-04-30
07331689120288Restylane-LQ-Med ABLMH2026-04-29
07331689120295Restylane-LQ-Med ABLMH2026-04-29
08437027710117SCULPTRASAIMA GLOBAL FARMA S.L.LMH2026-02-19
07640173236283RHA® Dynamic VolumeTeoxane SALMH2025-12-18
07640173236276RHA® Dynamic VolumeTeoxane SALMH2025-12-18
00362032907017saypha MagIQObagi Cosmeceuticals LLCLMH2025-11-27
00362032907024saypha MagIQ SAMPLEObagi Cosmeceuticals LLCLMH2025-11-27
07640123793309Belotero Balance LidocaineANTEIS SALMH2025-09-30
07640123793316Belotero Balance LidocaineANTEIS SALMH2025-09-30
08052570473434RadiesseDAMBO SRLLMH2025-09-25
08437027710063RESTYLANE DEFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710070RESTYLANE KYSSESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710087RESTYLANE LYFT WITH LIDOCAINESAIMA GLOBAL FARMA S.L.LMH2025-06-30
08437027710094RESTYLANE REFYNESAIMA GLOBAL FARMA S.L.LMH2025-06-30
07640173236177RHA® 3 MepiTeoxane SALMH2025-05-01
07640173236108RHA® 3 MepiTeoxane SALMH2025-05-01
03760172161264EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161271EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161288EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161295EVOLYSSE FORMSYMATESELMH2025-02-19
03760172161301EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03760172161318EVOLYSSE SMOOTHSYMATESELMH2025-02-19
03770034301103RadiesseUNIVERDERMLMH2024-12-02
03770034301097RadiesseUNIVERDERMLMH2024-12-02