Rongeur, Mastoid

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Shandong and Shanghai.

Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

How Is JZA Classified?

Rongeur, Mastoid is FDA product code JZA, Class 1, 21 CFR 874.4420.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Rongeur, Mastoid

MSI Precision Specialty Instruments

Hartman Mastoid Rongeur, Strong Curve, Overall Length 5-3/4"

Rongeur, Mastoid

Medicon

Citelli mastoid rong 17cm 1.5mm

Rongeur, Mastoid

Rongeur

Cutting, Antrum, Kerrison, Angled UP, 5 X 5 MM Jaws

Rongeur, Mastoid

Millennium

Kerrison Mastoid Rongeur 1.5mm

Rongeur, Mastoid

Integra® Jarit®

Integra® Jarit® Kerrison Mastoid Rongeur, 3-3/4", 4mm Bite

Rongeur, Mastoid

Integra®

Integra® Kerrison Rongeur, Size #0, 3.5 mm Bite

Rongeur, Mastoid

Integra® Miltex®

Integra® Miltex® Ruskin Rongeur 5-7/8", Curved, 3mm Bite, Double Action

Rongeur, Mastoid

Who Makes This Device Type in China?

How Is JZA Classified?

What Does It Take to Sell It in the United States?

MSI Precision Specialty Instruments

Medicon

Rongeur

Millennium

Integra® Jarit®

Integra®

Integra® Miltex®

Where China Actually Supplies