Mectron Ps Medical Torque Wrench

• FDA 510(k) K153743 decided 25 May 2016 Active
• FDA GUDID UDI-DI E322029000800010 listed 30 Aug 2016 Listed

1. 25 May 2016 Cleared FDA 510(k) K153743
2. 30 Aug 2016 Listed FDA GUDID E322029000800010

Trade name

Mectron

Generic name

Ultrasonic surgical system torque wrench, reusable

Model / Ref / Catalog

PS MEDICAL TORQUE WRENCH, 02900080-001

Primary DI / UDI-DI

E322029000800010

510(k) Number

K153743 ↗

FDA product code

HWE, HBE, JDX, ERL, DZI

GMDN term

Ultrasonic surgical system torque wrench, reusable

Device class

Class I

Regulation number

878.4820, 882.4310, 888.4580, 874.4250, 872.4120

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Ultrasonic surgical system torque wrench, reusable

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See all devices from Mectron SpA →