Sculptra

GUDID 07331689116106

Q-Med AB

Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral Dermal tissue reconstructive material, synthetic mineral

Primary Device ID	07331689116106
NIH Device Record Key	2a7478ed-3378-424a-bef9-c49f73a1710a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sculptra
Version Model Number	2 vial pack
Company DUNS	355371873
Company Name	Q-Med AB
Device Count	1
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 *Do Not Freeze
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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *Store at room temperature up to 30°C (86°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331689116106 [Primary]

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	2024-05-07
Device Publish Date	2024-04-29

On-Brand Devices [Sculptra ]

07331689116106	2 vial pack
07331689116113	1 vial pack-Sample

Trademark Results [Sculptra]

Mark Image Registration \| Serial	Company Trademark Application Date
SCULPTRA 85106833 not registered Dead/Abandoned	VALEANT INTERNATIONAL BERMUDA 2010-08-13
SCULPTRA 78266887 3056196 Live/Registered	NESTLÃ SKIN HEALTH S.A. 2003-06-25
SCULPTRA 77042446 not registered Dead/Abandoned	Aventis Pharmaceuticals Inc. 2006-11-13
SCULPTRA 73001341 0998950 Dead/Expired	CRANE CO. 1973-09-19