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) (10) Dilator, Urethral (KOE) (9)

Premarket Exempt

Clear

ConMed Inflation Device - 00653405052350 Catalog Number : 96282

Device Description : Inflation Device: 60mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Sphere™ Inflation Device - 00827002255715 Catalog Number : CID-20-30-NG

Device Description : Inflation Device Atrion Part Number 96469A: 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

Sphere™ Inflation Device - 00827002310278 Catalog Number : CID-20-30

Device Description : Inflation Device Atrion Part Number 96271A: 20mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

Sphere™ Inflation Device - 00827002349032 Catalog Number : CID-60-15

Device Description : Inflation Device Atrion Part Number 96378A: 60mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

Sphere™ Inflation Device - 00827002462830 Catalog Number : CID-25-15

Device Description : Inflation Device Atrion Part Number 96365: 25mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

Sphere™ Inflation Device - 00827002496743 Catalog Number : CID-40-15

Device Description : Inflation Device Atrion Part Number 96364A: 40mL, 15atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : KOE, MAV

Prescription Use : Yes

Device Count : 1

QL® Inflation Device - 00856877002001 Catalog Number : 96363

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 - 00856877002025 Catalog Number : 96402

Device Description : Inflation Device Atrion Part Number 96402: 25mL, 30atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

QL Locking Syringe Device - 00856877002032 Catalog Number : 96406

Device Description : Locking Syringe Device Atrion Part Number 96406: 38mL

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV

Prescription Use : Yes

Device Count : 1

QL Disposable Inflation Device - 00856877002049 Catalog Number : 96417

Device Description : Inflation Device: 40mL, 10atm

Device Class : 2

Duns Number: 047571476

Premarket Exempt : No

Product Code : MAV, KOE

Prescription Use : Yes

Device Count : 1

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