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, Ventricular, General & Plastic Surgery (GBS) (4) Instrument, Surgical, Disposable (KDC) (3) Catheter, Irrigation (GBX) (2) Tube, Double Lumen For Intestinal Decompression And/Or Intubation (FEG) (1)

Premarket Exempt

No Yes

Clear

Axiom® PVC - M6655222240 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222280 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222320 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® PVC - M6655222360 Catalog Number :

Device Description : Thoracic Catheter, Straight, PVC, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBS

Prescription Use : Yes

Device Count : 1

Axiom® Clamp Sleeves - M6656000 Catalog Number :

Device Description : Instrument Jaw Covers, Red

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : KDC

Prescription Use : Yes

Device Count : 1

Axiom® Clamp Sleeves - M6656100 Catalog Number :

Device Description : Instrument Jaw Covers, White

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : KDC

Prescription Use : Yes

Device Count : 1

Axiom® Clamp Sleeves - M6656200 Catalog Number :

Device Description : Instrument Jaw Covers, Blue

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : KDC

Prescription Use : Yes

Device Count : 1

Axiom® - M6657770700 Catalog Number :

Device Description : Sump Drain Suture Ring, Uni-Sump

Device Class : 2

Duns Number: 094439676

Premarket Exempt : No

Product Code : FEG

Prescription Use : Yes

Device Count : 1

Axiom® CWV Facial Atraum™ With ClotStop® - M665800410AT0 Catalog Number :

Device Description : Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Axiom® CWV - M6658036210 Catalog Number :

Device Description : Closed Wound Drain, Flat, Silicone, With Trocar

Device Class : 1

Duns Number: 094439676

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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