Machnet B.V.

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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

Coil, Magnetic Resonance, Specialty (MOS) (7)

Premarket Exempt

Clear

NA - B318PACCGD15501 Catalog Number : PACC-GD15-50

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - B318PACCGD30501 Catalog Number : PACC-GD30-50

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - B318PACCGS151 Catalog Number : PACC-GS15

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - B318PACCGS15HDX1 Catalog Number : PACC-GS15-HDx

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - B318PACCGS30HDX1 Catalog Number : PACC-GS30-HDx

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - B318PACCSS151 Catalog Number : PACC-SS15

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - B318PACCST301 Catalog Number : PACC-ST30

Device Description : Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imagi

Device Class : 2

Duns Number: 416060564

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

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