ATRION MEDICAL PRODUCTS, INC.

Address:1426 CURT FRANCIS RD.,ARAB,AL,35016,US

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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

Syringe, Balloon Inflation (MAV) (5) Dilator, Urethral (KOE) (4) Syringe, Balloon Inflation, Exempt (PTM) (1)

Premarket Exempt

Clear

QL Disposable Inflation Device - 00856877002650 Catalog Number : 96515

Device Description : Inflation Device Atrion Part Number 96515: 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Locking Syringe Device - 00856877002667 Catalog Number : 96503

Device Description : Locking Syringe Device Atrion Part Number 96503: 38mL

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV

Prescription Use : Yes

Device Count : 1

PAVmed™ Inflation Device - 00856877002711 Catalog Number : 96519

Device Description : Inflation Device Atrion Part Number 96519: 40mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : PTM

Prescription Use : Yes

Device Count : 1

OLYMPUS EndoTherapy™ Inflation Device for Biliary - 04953170195167 Catalog Number : MAJ-1381

Device Description : Inflation Device Atrion Part Number 96296: 20mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

ConMed Inflation Device - 10653405052357 Catalog Number : 96282

Device Description : Inflation Device: 60mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

angiodynamics NAMIC Disposable Inflation Device - H965459830 Catalog Number : H965459830

Device Description : Inflation Device Atrion Part Number 96468: 20mL, 30atm

Device Class :

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

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