Sculptra

GUDID 00302995961077

GALDERMA LABORATORIES, L.P.

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 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 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 ID00302995961077
NIH Device Record Key775d8e6f-de70-41b9-b0ff-ea1f030344c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSculptra
Version Model Number2 vial pack
Company DUNS047350186
Company NameGALDERMA LABORATORIES, L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature up to 30°C (86°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS100302995961077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-24
Device Publish Date2022-01-14

On-Brand Devices [Sculptra]

20302995961064Aesthetic
20302995961057HIV - Sample
20302995961040HIV
20302995961033Aesthetic - Sample
003029959610841 vial pack
003029959610772 vial pack

Trademark Results [Sculptra]

Mark Image

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

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