PUREGRAFT LLC

PUREGRAFT LLC

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Filters

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

System, Suction, Lipoplasty (MUU) (6) Instrument, Manual, Surgical, General Use (MDM) (1)

Premarket Exempt

No Yes

Clear

Puregraft - 00860407002218 Catalog Number : 250/PURE

Device Description : Puregraft 250 System (Made in USA)

Device Class : 2

Duns Number: 079508934

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Puregraft - 00860407002225 Catalog Number : 850/PURE

Device Description : Puregraft 850 System (Made in USA)

Device Class : 2

Duns Number: 079508934

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Dermapose Refresh Syringe Stand - 00860407002232 Catalog Number :

Device Class : 1

Duns Number: 079508934

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Puregraft MicroFat Transfer Kit - 00860407002270 Catalog Number :

Device Class :

Duns Number: 079508934

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Puregraft MicroFat Transfer Kit (19G) - 00860407002287 Catalog Number :

Device Class :

Duns Number: 079508934

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Puregraft MicroFat Transfer Kit (21G) - 00860407002294 Catalog Number :

Device Class :

Duns Number: 079508934

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Puregraft - 00863445000307 Catalog Number : 250/PURE

Device Description : Puregraft 250 System

Device Class : 2

Duns Number: 079508934

Premarket Exempt : No

Product Code : MUU

Prescription Use : No

Device Count : 1

Puregraft - 00863445000314 Catalog Number : 850/PURE

Device Description : Puregraft 850 System

Device Class : 2

Duns Number: 079508934

Premarket Exempt : No

Product Code : MUU

Prescription Use : No

Device Count : 1

Puregraft - 00863445000338 Catalog Number : 50/PURE

Device Description : Puregraft 50 System

Device Class :

Duns Number: 079508934

Premarket Exempt : No

Product Code : MUU

Prescription Use : No

Device Count : 5

Dermapose Refresh - 00863445000352 Catalog Number :

Device Class : 2

Duns Number: 079508934

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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