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) (9) Syringe, Balloon Inflation (MAV) (6) Dilator, Lachrymal (HNW) (4)

Premarket Exempt

Clear

QL® Inflation Device - 00856877002056 Catalog Number : 96419

Device Description : Inflation Device: 40mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002063 Catalog Number : 96313

Device Description : Inflation Device: 40mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002070 Catalog Number : 96197

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 - 00856877002087 Catalog Number : AQL 1015

Device Description : Inflation Device Atrion Part Number 96220: 10mL, 15atm

Device Class : 1

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, HNW

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002094 Catalog Number : 96241

Device Description : Inflation Device: 10mL, 15atm

Device Class : 1

Duns Number: 047571476

Premarket Exempt : No

Product Code : HNW, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002100 Catalog Number : 96252

Device Description : Inflation Device: 10mL, 30atm

Device Class : 1

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, HNW

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002117 Catalog Number : 96253

Device Description : Inflation Device: 10mL, 30atm

Device Class : 1

Duns Number: 047571476

Premarket Exempt : No

Product Code : HNW, KOE

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002124 Catalog Number : 96286

Device Description : Inflation Device: 20mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV

Prescription Use : Yes

Device Count : 1

QL® Inflation Device - 00856877002148 Catalog Number : 96295

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 - 00856877002162 Catalog Number : 96311

Device Description : Inflation Device: 25mL, 40atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

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