PuraGel 3mL 651-005

GUDID 00860007400308

PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 ml)

3-D MATRIX INC.

Synthetic peptide haemostatic agent
Primary Device ID00860007400308
NIH Device Record Key02e11a37-9c06-4894-ae16-eb2f7d717d53
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuraGel 3mL
Version Model Number651-005
Catalog Number651-005
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 Datefalse
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
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
GS100860007400308 [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 Date2023-09-28
Device Publish Date2023-09-20

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 3mL2023-09-28PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 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 5mL2022-07-21 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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