Punch, Skull

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shandong and Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

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

What Is FDA Product Code GXJ?

Punch, Skull is FDA product code GXJ, Class 1, 21 CFR 882.4750.

How Does It Reach the US Market?

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.

Punch, Skull

Punch

2 catalogue numbers from 99-568-61-01, listed by KLS-Martin L.P., United States, under Punch, Skull. 3 manufacturers in China are registered for this product code.

Punch, Skull

Aesculap

KERRISON Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), width: 3 mm, opening width: 10 mm, detachable, with ejector, thin, non-sterile, reusable

Punch, Skull

Which Manufacturers in China Make This?

What Is FDA Product Code GXJ?

How Does It Reach the US Market?

Punch

Aesculap

Where China Actually Supplies