Izi Medical Products, LLC

Address:5 Easter Ct Ste J,Owings Mills,MD,21117,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

Accelerator, Linear, Medical (IYE) (7) Neurological Stereotaxic Instrument (HAW) (2) Source, Brachytherapy, Radionuclide (KXK) (1)

Premarket Exempt

No Yes

Clear

Gold Fiducial - 00815212020209 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : KXK

Prescription Use : No

Device Count : 1

Fleximarc - 00815212020216 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Fleximarc - 00815212020223 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Fleximarc - 00815212020230 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Fleximarc - 00815212020247 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Fleximarc - 00815212020254 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Multi-Modality Markers - 00815212020261 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Multi-Modality Markers - 00815212020278 Catalog Number :

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Navigated Brain Biopsy Cannula - 00815212020285 Catalog Number :

Device Description : Navigate Brain Biopsy Cannula - Compatible BrainLab

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

Navigated Brain Biopsy Cannula - 00815212020292 Catalog Number :

Device Description : Navigated Brain Biopsy Cannula - Compatible Brainlab

Device Class : 2

Duns Number: 933506164

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

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