FDA.reportPublic FDA data

Sculptra

Primary DI
00302995961084
Brand
Sculptra
Company
GALDERMA LABORATORIES, L.P.
Model
1 vial pack
Published
2022-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
P030050034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030050034SCULPTRA AND SCULPTRA AESTHETICQ-Med AB2004-08-03LMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00302995961084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00302995961084003029959610843029959610840302995961084

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, Specify00 Store at room temperature up to 30°C (86°F)
Special Storage Condition, Specify00Do not freeze

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047350186
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00302995961077Sculptra2 vial pack2022-01-14
20302995961033SculptraAesthetic - Sample2014-10-10
20302995961040SculptraHIV2014-10-10
20302995961057SculptraHIV - Sample2014-10-10
20302995961064SculptraAesthetic2014-10-10

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
08437027710100SCULPTRASAIMA 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