FDA.reportPublic FDA data

3-D MATRIX, LTD.

Matched from indexed company URL: 3-D Matrix, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
300716265830071626583-D MATRIX, LTD.1N2026-01-01Frontier Kojimachi Building 7F, Kojimachi 3-2-4 Chiyoda-ku Tokyo JP 102-0083
301552814630155281463-D MATRIX, INC.1Y2026-01-011234 Chestnut St. Suite 205 Newton MA US 02464

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2293731911385214K222481PuraStatQAU2023-02-28
2293731810896090K213552PuraStat-RMPHN2022-04-01
2293731085520798K210211PuraStat-OMOLR2021-10-08
2332781047879833K210098PuraStat-GIQAU2021-06-25
2293731468014009K210098PuraStat-GIQAU2021-06-25
2293731373202383K183015PuraSinusNHB2019-04-12
2332781788935876K183015PuraSinusNHB2019-04-12
2293731132390585
2332781312703124

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QAU32023-02-28
NHB32019-04-12
PHN12022-04-01
OLR12021-10-08

PMN#

GUDID#

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)

3-D MATRIX INC.

2023-08-28

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).

3-D MATRIX INC.

2023-08-28

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)

3-D MATRIX INC.

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)

3-D MATRIX INC.

2023-09-20

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)

3-D MATRIX INC.

2023-09-20