FDA.reportPublic FDA data

BELLAFILL

Primary DI
00350224000141
Brand
BELLAFILL
Company
SUNEVA MEDICAL, INC.
Model
1.5 cc
Catalog number
GBF0115, GBF0215, GBF0315
Device description
Bellafill 1.5ml on 1.5cc syringe
Published
2022-09-13
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMHImplant, Dermal, For Aesthetic UseUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10350224000148PackageGS13In Commercial Distribution
20350224000145PackageGS11In Commercial Distribution
30350224000142PackageGS12In Commercial Distribution
00350224000141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035022400014810350224000148
2035022400014520350224000145
3035022400014230350224000142
00350224000141003502240001413502240001410350224000141

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
858-550-9999customersupport@sunevamedical.com

Regulatory Flags#

DUNS number
012844615
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00350224000035SKIN TEST0.3ccGBS05012019-03-19
00350224000004ARTEFILL 8021 AF0508 2014-09-24
00350224000028BELLAFILL1.0 ccGBF0208, GBF05082014-12-01
00350224000103Amplifine15mlSM-PRP-152020-12-31
00350224000110Amplifine30mlSM-PRP-302020-12-31
00350224000158AmplifineBD Vacutainer and TorniquetSM-PRP-VT-102022-02-10
00350224000165AmplifineBD Large Holder VacutainerSM-PRP-LV-102022-02-10
00350224000127Amplifine15ml - BDSM-PRP-15-BD2020-12-31
00350224000134Amplifine30ml - BDSM-PRP-30-BD2020-12-31
10350224000148BELLAFILL1.5 ccGBF0115, GBF0215, GBF03152022-09-13
10350224000100Amplifine15mlSM-PRP-152020-12-31
10350224000117Amplifine30mlSM-PRP-302020-12-31
10350224000032SKIN TEST0.3ccGBS05012019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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