SpaceOAR Vue Hydrogel
Augmenix, Inc
AUGMENIX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008550999 | 3008550999 | AUGMENIX, INC. | 1 | N | 2020-04-25 | 201 Burlington Road Bedford MA US 01730 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 223833 | 1306045140 | K151998 | TraceIT Tissue Marker - 3mL | NEU | 2015-08-19 |
| 223833 | 1418565252 | K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | NEU | 2013-01-23 |
| 223833 | 1562199688 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NEU | 2 | 2015-08-19 |
PMN#
SpaceOAR System
Augmenix, Inc.
TraceIT Tissue Marker - 3mL
AUGMENIX, INC.
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
AUGMENIX , INC.
GUDID#
TraceIT Tissue Marker 1-UP - 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.
2015-12-10
TraceIT Tissue Marker 3mL 1-UP - 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.
2015-12-10
TraceIT Tissue Marker 5-UP - 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.
2015-12-11
TraceIT Tissue Marker 3mL 5-UP - 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.
2015-12-11