FDA.reportPublic FDA data

Radiesse

Primary DI
05060432190033
Brand
Radiesse
Company
FCL HEALTH SOLUTIONS LTD
Model
NA
Published
2015-07-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMHImplant, Dermal, For Aesthetic Use
PKYImplant, Dermal, For Aesthetic Use In The Hands

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3
PKYImplant, Dermal, For Aesthetic Use In The HandsUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060432190033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060432190033050604321900335060432190033

GMDN Terms#

Term, Definition table
TermDefinition
Synovial fluid supplementation mediumA sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999info@fclhealth.com

Regulatory Flags#

DUNS number
219706976
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25060432190006SYNVISCHYLAN GF-202015-05-26
15060432190009SYNVISC ONEHYLAN GF-202015-05-26
65060432190004SYNVISCHYLAN GF-202015-05-26
35060432190003HYALGANNone2015-05-26
45060432190000EuflexxaNA2015-05-29
75060432190001OrthoviscNone2015-05-29
05060432190019SupartzNA2015-07-08
05060432190026MonoviscNA2015-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057607270031Juvederm VolbellaNUVARA SRLLMH2026-10-15
08057607270048Juvederm VoluxNUVARA SRLLMH2026-10-15
08057607270055Juvederm VolumaNUVARA SRLLMH2026-10-15
08057607270086RadiesseNUVARA SRLLMH2026-10-15
08057607270093Restylane LidoNUVARA SRLLMH2026-10-15
08057607270109Restylane LyftNUVARA SRLLMH2026-10-15
08057607270116Restylane RefyneNUVARA SRLLMH2026-10-15
08057607270123Restylane KysseNUVARA SRLLMH2026-10-15
08057607270130Restylane DefyneNUVARA SRLLMH2026-10-15
08057607270147SculptraNUVARA SRLLMH2026-10-15
07640123792982Belotero Volume (+) LidocaineANTEIS SALMH2026-08-08
07640123792999Belotero Volume (+) LidocaineANTEIS SALMH2026-08-08
04262487270222Radiesse (+) LidocainePharmamondis GmbHLMH2026-06-24
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