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 ID: 00860001820829
• NIH Device Record Key: bd7c5e5e-b04c-4b37-87ca-ebbb9bd92bb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraSinus 5mL
• Version Model Number: 651-009
• Company DUNS: 058207695
• Company Name: 3-D MATRIX INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001820829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183015

FDA Product Code

• NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

Devices Manufactured by 3-D MATRIX INC.

• 00860001820898 - PuraGel 5mL: 2023-09-28 PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (5 ml)
• 00860007400308 - PuraGel 3mL: 2023-09-28 PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 ml)
• 00860007400315 - PuraGel 1mL: 2023-09-28 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 5mL: 2022-07-21PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
• 00860001820829 - PuraSinus 5mL: 2022-07-21 PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
• 00860001820836 - PuraSinus 3mL: 2022-07-21 PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
• 00860001820843 - PuraSinus 1mL: 2022-07-21 PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (1 mL)