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

Dilator, Urethral (KOE) (10) Syringe, Balloon Inflation (MAV) (10)

Premarket Exempt

Clear

QL Disposable Inflation Device - 00856877002179 Catalog Number : 96314

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

Medtronic Disposable Inflation Device - 00856877002186 Catalog Number : 96491

Device Description : Inflation Device: 8mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

TRACOE technic® Disposable Inflation Device - 00856877002193 Catalog Number : 725

Device Description : Inflation Device Atrion Part Number 96492: 25mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002209 Catalog Number : 96351

Device Description : Inflation Device: 14mL, 55atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002216 Catalog Number : 96358

Device Description : Inflation Device: 25mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Stryker Interventional Spine iVAS™ Inflator - 00856877002247 Catalog Number : 0705-810-201

Device Description : Inflation Device: 14mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Stryker iVAS® Elite Inflator - 00856877002254 Catalog Number : 0808-100-001

Device Description : Inflation Device Atrion Part Number 96485: 14mL, 700psi

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002261 Catalog Number : 96394

Device Description : Inflation Device : 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002278 Catalog Number : 96405

Device Description : Inflation Device: 14mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

Stryker AVA/iVAS® Inflator - 00856877002285 Catalog Number : 1031-115-400

Device Description : Inflation Device Atrion Part Number 96493: 14mL, 400psi

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

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