ARTEFILL AF0508

GUDID 00350224000004

SUNEVA MEDICAL, INC.

Dermal tissue reconstructive material, animal-derived
Primary Device ID00350224000004
NIH Device Record Key996f50aa-fdf7-4925-a78b-e3990b114ce1
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTEFILL
Version Model Number8021
Catalog NumberAF0508
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

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
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100350224000004 [Primary]
GS110350224000001 [Package]
Package: 5 syringe per box [5 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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by SUNEVA MEDICAL, INC.

10350224000148 - BELLAFILL2022-09-21 Bellafill 1.5ml on 1.5cc syringe
00350224000158 - Amplifine2022-02-18 Amplifine HD PRP convenience kit. BD Vacutainer & Tourniquet, 10 pack
00350224000165 - Amplifine2022-02-18 Amplifine HD PRP convenience kit. Large Holder 30ml Vacutainer, 10 pack.
10350224000100 - Amplifine2021-01-08 Amplifine HD PRP tube 15ml
10350224000117 - Amplifine2021-01-08 Amplifine HD PRP Tube 30ml
00350224000127 - Amplifine2021-01-08 Amplifine HD PRP Tube 15ml, Blood Draw Kit
00350224000134 - Amplifine2021-01-08 Amplifine HD PRP Tube 30ml, Blood Draw kit
10350224000032 - SKIN TEST2019-03-27 Skin Test 0.3cc syringe

Trademark Results [ARTEFILL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARTEFILL
ARTEFILL
75788742 2944130 Live/Registered
SUNEVA MEDICAL, INC.
1999-08-31

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