PFM MEDICAL INCORPORATED

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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

Catheter, Embolectomy (DXE) (5) Needle, Catheter (GCB) (4) Apparatus, Suction, Patient Care (DWM) (1)

Premarket Exempt

No Yes

Clear

BBraun Multi-Snare - 00813623011281 Catalog Number : 612972

Device Description : Multi-Snare Set 5mm x 125cm

Device Class :

Duns Number: 097736867

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

BBraun Multi-Snare - 00813623011298 Catalog Number : 612973

Device Description : Multi-Snare Set 10mm x 125cm

Device Class :

Duns Number: 097736867

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

BBraun Multi-Snare - 00813623011304 Catalog Number : 612974

Device Description : Multi-Snare Set 15mm x 125cm

Device Class :

Duns Number: 097736867

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

BBraun Multi-Snare - 00813623011311 Catalog Number : 612975

Device Description : Multi-Snare Set 20mm x 125cm

Device Class :

Duns Number: 097736867

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

BBraun Multi-Snare - 00813623011328 Catalog Number : 612976

Device Description : Multi-Snare Set 30mm x 125cm

Device Class :

Duns Number: 097736867

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Jet-Vac Procedure Trays - 00813623011335 Catalog Number : M7854SC

Device Description : Scripps 5F x 10cm Jet-Vac® Procedure Trays

Device Class : 1

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : GCB

Prescription Use : Yes

Device Count : 1

Jet-Vac Procedure Trays - 00813623011342 Catalog Number : M7854P

Device Description : Palomar 5F x 10cm Jet-Vac® Procedure Trays

Device Class : 1

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : GCB

Prescription Use : Yes

Device Count : 1

ASEPT Pleural Drainage System - 00813623011359 Catalog Number : M7031

Device Description : ASEPT Pleural Drainage System

Device Class : 2

Duns Number: 097736867

Premarket Exempt : No

Product Code : DWM

Prescription Use : Yes

Device Count : 1

Jet-Vac Procedure Trays - 00813623011366 Catalog Number : M7853

Device Description : 5F x 7cm Jet-Vac® Procedure Trays

Device Class : 1

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : GCB

Prescription Use : Yes

Device Count : 1

Jet-Vac Procedure Trays - 00813623011373 Catalog Number : M7854

Device Description : 5F x 10cm Jet-Vac® Procedure Trays

Device Class : 1

Duns Number: 097736867

Premarket Exempt : Yes

Product Code : GCB

Prescription Use : Yes

Device Count : 1

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