Fibrin Sealant Preparation Device

Device Code: 2452

Product Code(s): MZM

Device Classification Information

• Device Type ID: 2452
• Device Name: Fibrin Sealant Preparation Device
• Regulation Description: Piston Syringe.
• Regulation Medical Specialty: General Hospital
• Review Panel: Hematology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5860 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MZM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2452
• Device: Fibrin Sealant Preparation Device
• Product Code: MZM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Piston Syringe.
• CFR Regulation Number: 880.5860 [🔎]

Premarket Reviews
Manufacturer	Decision
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
ETHICON INC.
	SUBSTANTIALLY EQUIVALENT	1
OMRIX BIOPHARMACEUTICALS LTD.
	SUBSTANTIALLY EQUIVALENT	1
PLASTMED, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Material Discolored	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:12:37