PuraSinus 5mL

GUDID 00860001820829

PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)

3-D MATRIX INC.

Intranasal splint, biodegradable
Primary Device ID00860001820829
NIH Device Record Keybd7c5e5e-b04c-4b37-87ca-ebbb9bd92bb2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuraSinus 5mL
Version Model Number651-009
Company DUNS058207695
Company Name3-D MATRIX INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001820829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-21
Device Publish Date2022-07-13

Devices Manufactured by 3-D MATRIX INC.

00860001820898 - PuraGel 5mL2023-09-28 PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml)
00860007400308 - PuraGel 3mL2023-09-28 PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 ml)
00860007400315 - PuraGel 1mL2023-09-28 PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (1 ml)
00860001820867 - PuraStat (1mL)2023-09-05 PuraStat Gel is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (1 mL).
00860001820874 - PuraStat (3mL)2023-09-05 PuraStat is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (3 mL)
00860001820829 - PuraSinus 5mL2022-07-21PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
00860001820829 - PuraSinus 5mL2022-07-21 PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
00860001820836 - PuraSinus 3mL2022-07-21 PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
00860001820843 - PuraSinus 1mL2022-07-21 PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)

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