BELLAFILL GBF0208, GBF0508

GUDID 00350224000028

Bellafill 1.0cc syringe

SUNEVA MEDICAL, INC.

Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived Dermal tissue reconstructive material, animal-derived
Primary Device ID00350224000028
NIH Device Record Keya1f7297f-4d4b-48de-92c6-3d05fd8391fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBELLAFILL
Version Model Number1.0 cc
Catalog NumberGBF0208, GBF0508
Company DUNS012844615
Company NameSUNEVA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com
Phone858-550-9999
Emailcustomersupport@sunevamedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT FREEZE
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100350224000028 [Primary]
GS110350224000025 [Package]
Package: 5 syringes per box [5 Units]
In Commercial Distribution
GS120350224000022 [Package]
Package: 2 syringes per box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2014-12-01

On-Brand Devices [BELLAFILL]

00350224000028Bellafill 1.0cc syringe
10350224000148Bellafill 1.5ml on 1.5cc syringe

Trademark Results [BELLAFILL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BELLAFILL
BELLAFILL
86394676 4844046 Live/Registered
Suneva Medical, Inc.
2014-09-15
BELLAFILL
BELLAFILL
85188311 4199232 Live/Registered
Suneva Medical, Inc.
2010-12-01

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