SCULPTRA

GUDID 08437027710100

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.

SAIMA GLOBAL FARMA S.L.

Dermal tissue reconstructive material, synthetic mineral

• Primary Device ID: 08437027710100
• NIH Device Record Key: 2dbfc1dd-7aa1-4a12-af65-8e0ddb9e529a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCULPTRA
• Version Model Number: 2 Vials
• Company DUNS: 468910220
• Company Name: SAIMA GLOBAL FARMA S.L.
• Device Count: 2
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required
• 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 *Refrigeration not required

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437027710100 [Unit of Use]
GS1	08437027710117 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-27
• Device Publish Date: 2026-02-19

Devices Manufactured by SAIMA GLOBAL FARMA S.L.

• 08437027710100 - SCULPTRA: 2026-02-27SCULPTRA 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.
• 08437027710100 - SCULPTRA: 2026-02-27 SCULPTRA is a sterile, injectable, biocompatible, biodegradable material that is made of poly-L-lactic acid (a synthetic polymer
• 08437027710063 - RESTYLANE DEFYNE: 2025-07-08 RESTYLANE DEFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of li
• 08437027710070 - RESTYLANE KYSSE: 2025-07-08 RESTYLANE KYSSE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lid
• 08437027710087 - RESTYLANE LYFT WITH LIDOCAINE: 2025-07-08 RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin wi
• 08437027710094 - RESTYLANE REFYNE: 2025-07-08 RESTYLANE REFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of li
• 08437027710001 - DUROLANE: 2024-11-21 DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock
• 08437027710018 - MONOVISC: 2024-11-21 MONOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in th
• 08437027710025 - ORTHOVISC: 2024-11-21 ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in t