Medetz Surgical Instruments

Basic Information

• Brand Name: Medetz Surgical Instruments
• Primary DI: G2231318060
• Version / Model: 13-1806
• Company Name: Medetz Surgical Instruments LLC
• Labeler DUNS: 876570990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-23
• Public Version: 2
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: eee54a94-c4e9-474e-8c04-c58b3e144123

Device Description

Septum Needle, 22g TW 0.8mm, OL129mm (5 1/8")

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38824	General-purpose endoscopic needle, reusable	A flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G2231318060	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]