ARTEFILL AF0508
GUDID 00350224000004
SUNEVA MEDICAL, INC.
Dermal tissue reconstructive material, animal-derived| Primary Device ID | 00350224000004 |
| NIH Device Record Key | 996f50aa-fdf7-4925-a78b-e3990b114ce1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTEFILL |
| Version Model Number | 8021 |
| Catalog Number | AF0508 |
| Company DUNS | 012844615 |
| Company Name | SUNEVA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00350224000004 [Primary] |
| GS1 | 10350224000001 [Package] Package: 5 syringe per box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P020012
FDA Product Code
| LMH | Implant, Dermal, For Aesthetic Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-24 |
Devices Manufactured by SUNEVA MEDICAL, INC.
| 10350224000148 - BELLAFILL | 2022-09-21 Bellafill 1.5ml on 1.5cc syringe |
| 00350224000158 - Amplifine | 2022-02-18 Amplifine HD PRP convenience kit. BD Vacutainer & Tourniquet, 10 pack |
| 00350224000165 - Amplifine | 2022-02-18 Amplifine HD PRP convenience kit. Large Holder 30ml Vacutainer, 10 pack. |
| 10350224000100 - Amplifine | 2021-01-08 Amplifine HD PRP tube 15ml |
| 10350224000117 - Amplifine | 2021-01-08 Amplifine HD PRP Tube 30ml |
| 00350224000127 - Amplifine | 2021-01-08 Amplifine HD PRP Tube 15ml, Blood Draw Kit |
| 00350224000134 - Amplifine | 2021-01-08 Amplifine HD PRP Tube 30ml, Blood Draw kit |
| 10350224000032 - SKIN TEST | 2019-03-27 Skin Test 0.3cc syringe |
Trademark Results [ARTEFILL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTEFILL 75788742 2944130 Live/Registered |
SUNEVA MEDICAL, INC. 1999-08-31 |
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