FibriJet

Basic Information

• Brand Name: FibriJet
• Primary DI: 00815634021747
• Version / Model: 800-0251
• Company Name: Micromedics, Inc.
• Labeler DUNS: 066839630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-08
• Public Version: 2
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: b2b7e516-bc03-4acd-9faf-32024b52f923

Device Description

DUAL RATIO APPLICATOR KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44830	Open-surgery adhesive/sealant applicator, dual-channel	A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815634021744	GS1	Inner Pack	1	In Commercial Distribution
Primary	00815634021747	GS1
Package	20815634021741	GS1	Case	70	In Commercial Distribution