AUGMENIX, INC.

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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

Marker, Radiographic, Implantable (NEU) (2) Hydrogel Spacer (OVB) (1)

Premarket Exempt

Clear

SpaceOAR System - 00864661000102 Catalog Number : SO-2101

Device Description : The SpaceOAR System consists of components for preparation of a synthetic, absor The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.

Device Class : 2

Duns Number: 960905862

Premarket Exempt : No

Product Code : OVB

Prescription Use : Yes

Device Count : 1

TraceIT Tissue Marker 1-UP - 00864661000119 Catalog Number : TH-1011

Device Description : TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-fil TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.

Device Class : 2

Duns Number: 960905862

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

TraceIT Tissue Marker 3mL 1-UP - 00864661000133 Catalog Number : TH-1031

Device Class : 2

Duns Number: 960905862

Premarket Exempt : No

Product Code : NEU

Prescription Use : Yes

Device Count : 1

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