BELLAFILL

Basic Information

• Brand Name: BELLAFILL
• Primary DI: 00350224000141
• Version / Model: 1.5 cc
• Catalog Number: GBF0115, GBF0215, GBF0315
• Company Name: SUNEVA MEDICAL, INC.
• Labeler DUNS: 012844615
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-13
• Public Version: 1
• Public Version Date: 2022-09-21
• Public Version Status: New
• Public Device Record Key: 9251ea54-60a7-47c5-948f-79c6a905b5a6

Device Description

Bellafill 1.5ml on 1.5cc syringe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMH	Implant, Dermal, For Aesthetic Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
59130	Dermal tissue reconstructive material, animal-derived	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350224000148	GS1	Carton	3	In Commercial Distribution
Primary	00350224000141	GS1
Package	20350224000145	GS1	Carton	1	In Commercial Distribution
Package	30350224000142	GS1	Carton	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P020012	039

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Freeze