AXIOM MEDICAL, INCORPORATED

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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

Catheter And Tip, Suction (JOL) (6) Catheter, Ventricular, General & Plastic Surgery (GBS) (4)

Premarket Exempt

No Yes

Clear

Axiom® - M665100024S0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With Scale

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Axiom® - M665100024SC0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Axiom® - M6651000280 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Axiom® Atraum™ With ClotStop® - M665100028AT0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With ClotStop®

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® Atraum™ With ClotStop® - M665100028ATS0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With Scale, With ClotStop®

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® Atraum™ With ClotStop® - M665100028ATSC0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched, With ClotStop®

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® Atraum™ With ClotStop® - M665100028ATX0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With ClotStop®, Special Length

Device Class :

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® - M665100028S0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With Scale

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Axiom® - M665100028SC0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone, With Scale, Double Pouched

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Axiom® - M665100028XSP0 Catalog Number :

Device Description : Thoracic Catheter, Straight, Silicone

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : JOL

Prescription Use : Yes

Device Count : 1

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