PuraStat
3-D Matrix Europe SAS
3-D MATRIX, LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007162658 | 3007162658 | 3-D MATRIX, LTD. | 1 | N | 2026-01-01 | Frontier Kojimachi Building 7F, Kojimachi 3-2-4 Chiyoda-ku Tokyo JP 102-0083 |
| 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 | 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 |
| 233278 | 1047879833 | K210098 | PuraStat-GI | QAU | 2021-06-25 |
| 229373 | 1468014009 | K210098 | PuraStat-GI | QAU | 2021-06-25 |
| 229373 | 1373202383 | K183015 | PuraSinus | NHB | 2019-04-12 |
| 233278 | 1788935876 | K183015 | PuraSinus | NHB | 2019-04-12 |
| 229373 | 1132390585 | ||||
| 233278 | 1312703124 |
Product Codes Associated With Registrations#
PMN#
PuraStat
3-D Matrix Europe SAS
PuraStat
3-D Matrix, Inc.
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.
GUDID#
PuraGel 5mL - PuraGel™ is a space-occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraGel™ is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period. PuraGel™ is also indicated to adhere to oral tissue and form a protective barrier over the wound to prevent irritation and contamination to manage the pain in all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It provides a moist wound environment required for optimal wound healing. (5 ml)
2023-09-20
PuraGel 3mL - PuraGel™ is a space-occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraGel™ is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period. PuraGel™ is also indicated to adhere to oral tissue and form a protective barrier over the wound to prevent irritation and contamination to manage the pain in all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It provides a moist wound environment required for optimal wound healing. (3 ml)
2023-09-20
PuraGel 1mL - PuraGel™ is a space-occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraGel™ is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period. PuraGel™ is also indicated to adhere to oral tissue and form a protective barrier over the wound to prevent irritation and contamination to manage the pain in all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It provides a moist wound environment required for optimal wound healing. (1 ml)
2023-09-20
PuraStat (1mL) - PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding. PuraStat is also indicated for the symptomatic management of Rectal Mucositis (RM), such as radiation proctitis that may be caused by chemotherapy or radiotherapy. (1 mL).
2023-08-28
PuraStat (3mL) - PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding. PuraStat is also indicated for the symptomatic management of Rectal Mucositis (RM), such as radiation proctitis that may be caused by chemotherapy or radiotherapy. (3 mL)
2023-08-28
PuraStat - 621-035
2025-03-03
PuraStat - 621-043
2026-02-01
PuraSinus 5mL - PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
2022-07-13
PuraSinus 3mL - PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
2022-07-13
PuraSinus 1mL - PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)
2022-07-13