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 Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent Synthetic peptide haemostatic agent

• Primary Device ID: 00860007400308
• NIH Device Record Key: 02e11a37-9c06-4894-ae16-eb2f7d717d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PuraGel 3mL
• Version Model Number: 651-005
• Catalog Number: 651-005
• 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: false
• 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
• 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	00860007400308 [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: 2023-09-28
• Device Publish Date: 2023-09-20

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: 2023-09-28PuraGel is a hemostat for mild and moderate bleeding intended to be used in a variety of indications. (3 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: 2022-07-21 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)