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) (9)

Premarket Exempt

Clear

QL Disposable Inflation Device - 00856877002292 Catalog Number : 96450

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 - 00856877002308 Catalog Number : 96438

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

panmed u.s. PAN MEDICAL Disposable Inflation Device - 00856877002315 Catalog Number : 96496

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 - 00856877002322 Catalog Number : 96497

Device Description : Inflation Device: 14mL, 55atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

LB Medical Disposable Inflation Device - 00856877002339 Catalog Number : 96420

Device Description : Inflation Device: 10mL, 20atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE

Prescription Use : Yes

Device Count : 1

AERIS Inflation Device - 00856877002346 Catalog Number : 96499

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

QL Disposable Inflation Device - 00856877002353 Catalog Number : 96424

Device Description : Inflation Device: 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002360 Catalog Number : 96500

Device Description : Inflation Device: 10mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002377 Catalog Number : 96501

Device Description : Inflation Device: 10mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002384 Catalog Number : 96502

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

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