FDA.reportPublic FDA data

Radiesse

Primary DI
05060457760082
Brand
Radiesse
Company
LAMBSMEAD LTD
Model
8071M5K1
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
MIXSystem, Vocal Cord Medialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIXSystem, Vocal Cord MedializationEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060457760082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060457760082050604577600825060457760082

GMDN Terms#

Term, Definition table
TermDefinition
Dermal tissue reconstructive material, animal-derivedA sterile, bioabsorbable, animal-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), to correct cutaneous contour deformities (e.g., scars) associated with aging, injury, or degenerative lesions; it may in addition be used as a bulking material for incontinence treatment (e.g., in the urinary tract). It does not include a local anaesthetic agent. It includes animal-derived collagen or hyaluronic acid (HA) [e.g., porcine, bovine]. It is typically preloaded in a disposable syringe.

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
05060457760099Restylane 1 ML.110872015-10-24
05060457760105Restylane + Lidocaine110522015-10-24
05060457760112Restylane Lip Refresh94316JR2015-10-24
05060457760129Restylane 0.5 ML.+ Lidocaine1701012015-10-24
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
00810235030846Prolaryn Gel MERZ NORTH AMERICA, INC.MIX2026-02-24
14063107101752Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101769Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101776Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101783Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101790Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101806Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101813Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101820Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101837Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101844Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101851Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101868Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102629Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
14063107102636Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
34063107101756Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101763Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101770Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101787Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101794Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101800Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101817Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101824Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101831Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101848Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101855Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101862Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102483Montgomery® Thyroplasty Instrument SetBoston Medical Products, Inc.MIX2022-08-31
14063107102490Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31
14063107102506Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31