ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE

Basic Information

• Brand Name: ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE
• Primary DI: B09929010920
• Version / Model: 2901-092
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 5
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 8047acfd-3498-4cad-adc9-deb818359fc9
• Distribution End Date: 2018-09-22

Device Description

ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RATCHET/RELEASE KEY, ROTATION MODULE AND HIGH FREQUENCY

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32043	Laparoscopic surgical procedure kit, non-medicated, reusable	A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B09929010920	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS