Fibrijet

Basic Information

• Brand Name: Fibrijet
• Primary DI: 00815634021761
• Version / Model: SA-3445
• Company Name: Micromedics, Inc.
• Labeler DUNS: 066839630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-18
• Public Version: 2
• Public Version Date: 2025-06-23
• Public Version Status: Update
• Public Device Record Key: 8caccfc0-7d06-4843-96f7-4a12922ab93b

Device Description

Endoscopic Catheter Introducer

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGZ	Accessories, Catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67059	Endoscopic catheter introducer	A non-dedicated, rigid, tubular device, supplied independently of other devices, intended to be percutaneously inserted through a trocar blade during an endoscopic procedure (i.e., pleuroscopic or laparoscopic) for insertion of a flexible catheter/cannula (typically a haematological concentrate/haemostatic agent applicator cannula) through its lumen. It is not intended for introduction of endoscopic instruments and does not include a shut-off valve. Neither an obturator nor other procedural devices are included (i.e., not a set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815634021768	GS1	Inner Pack	3	In Commercial Distribution
Primary	00815634021761	GS1