PuraStat
3-D Matrix, Inc.
3-D MATRIX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015528146 | 3015528146 | 3-D MATRIX, INC. | 1 | Y | 2026-01-01 | 1234 Chestnut St. Suite 205 Newton MA US 02464 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 229373 | 1737694053 | K261504 | PuraStat-RM | PHN | 2026-08-03 |
| 229373 | 1046080608 | K261503 | PuraStat GI | QAU | 2026-08-03 |
| 229373 | 1911385214 | K222481 | PuraStat | QAU | 2023-02-28 |
| 229373 | 1810896090 | K213552 | PuraStat-RM | PHN | 2022-04-01 |
| 229373 | 1085520798 | K210211 | PuraStat-OM | OLR | 2021-10-08 |
| 229373 | 1468014009 | K210098 | PuraStat-GI | QAU | 2021-06-25 |
| 229373 | 1373202383 | K183015 | PuraSinus | NHB | 2019-04-12 |
| 229373 | 1132390585 |
Product Codes Associated With Registrations#
PMN#
PuraStat-RM
3-D Matrix, Inc.
PuraStat-OM
3-D Matrix, Inc.
PuraStat-GI
3-D Matrix, Inc.
PuraDERM Gel
3-D Matrix, Inc.
PuraSinus
3-D Matrix, Inc.
PuraDerm Gel
3-D Matrix, Inc.