SUNEVA MEDICAL, INC.

Address:5870 Pacific Center Blvd,San Diego,CA,92121,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Platelet And Plasma Separator For Bone Graft Handling (ORG) (6) Implant, Dermal, For Aesthetic Use (LMH) (4)

Premarket Exempt

No Yes

Clear

ARTEFILL - 00350224000004 Catalog Number : AF0508

Device Class :

Duns Number: 012844615

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

BELLAFILL - 00350224000028 Catalog Number : GBF0208, GBF0508

Device Description : Bellafill 0.8ml on 1.0cc syringe

Device Class :

Duns Number: 012844615

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

SKIN TEST - 00350224000035 Catalog Number : GBS0501

Device Description : Skin Test 0.3ml in 1.0cc syringe

Device Class :

Duns Number: 012844615

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Amplifine - 00350224000103 Catalog Number : SM-PRP-15

Device Description : Amplifine HD PRP tube 15ml

Device Class :

Duns Number: 012844615

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Amplifine - 00350224000110 Catalog Number : SM-PRP-30

Device Description : Amplifine HD PRP Tube 30ml

Device Class :

Duns Number: 012844615

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Amplifine - 00350224000127 Catalog Number : SM-PRP-15-BD

Device Description : Amplifine HD PRP Tube 15ml, Blood Draw Kit

Device Class : 2

Duns Number: 012844615

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Amplifine - 00350224000134 Catalog Number : SM-PRP-30-BD

Device Description : Amplifine HD PRP Tube 30ml, Blood Draw kit

Device Class : 2

Duns Number: 012844615

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

BELLAFILL - 00350224000141 Catalog Number : GBF0115, GBF0215, GBF0315

Device Description : Bellafill 1.5ml on 1.5cc syringe

Device Class :

Duns Number: 012844615

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Amplifine - 00350224000158 Catalog Number : SM-PRP-VT-10

Device Description : Amplifine HD PRP convenience kit.Collection Set & Tourniquet, 10 pack

Device Class : 2

Duns Number: 012844615

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Amplifine - 00350224000165 Catalog Number : SM-PRP-LV-10

Device Description : Amplifine HD PRP convenience kit.Large Holder 30ml Collection Set, 10 pack.

Device Class : 2

Duns Number: 012844615

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

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