FDA.reportPublic FDA data

Restylane 0.5 ML.+ Lidocaine

Primary DI
05060457760129
Brand
Restylane 0.5 ML.+ Lidocaine
Company
LAMBSMEAD LTD
Model
170101
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060457760129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060457760129050604577601295060457760129

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, microbe-derived, anaestheticA sterile, bioabsorbable, bacteria-derived substance 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 includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
235542735
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060457760006Juvederm Volbella94728JR2015-10-24
05060457760013Juvederm Volift94201JR2015-10-24
05060457760020Juvederm Voluma94506JR2015-10-24
05060457760037Juvederm Ultra 494553JR2015-10-24
05060457760044Juvederm Ultra Smile94131JR2015-10-24
05060457760051Juvederm Ultra 394555JR2015-10-24
05060457760068Juvederm Ultra 294127JR2015-10-24
05060457760075Juvederm Hydrate93942JR2015-10-24
05060457760082Radiesse8071M5K12015-10-24
05060457760099Restylane 1 ML.110872015-10-24
05060457760105Restylane + Lidocaine110522015-10-24
05060457760112Restylane Lip Refresh94316JR2015-10-24
05060457760136Restylane Lip Volume94529JR2015-10-24
05060457760143Restylane Perlane1073362015-10-24
05060457760150Restylane Perlane + Lidocaine1082932015-10-24
05060457760167Restylane Sub-Q1106352015-10-24
05060457760174Restylane Vital 1 ML.10704012015-10-24
05060457760181Restylane Vital 1 ML.10706032015-10-24
05060457760198Sculptra890262962015-10-24
05060457760204Belotero Soft53120L2015-10-24

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