Surgical procedure kit, general-purpose, single-use, non-medicated

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Medi Dent Disposable International

Class:

Class IIa

Manufactured by:

Nanjing Sealand Medical Co Ltd No 13 Shen Yuan Road, Li Shui Development Zone, Nanjing, 211200 China

Therapeutic area:

33961 - Surgical procedure kit, general-purpose, single-use, non-medicated

Therapeutic indications:

The device consists of a collection of disposable, single use, hand held, non-active surgical instruments, dressing materials and components presented in a sterile pack. The device is intended to be used by health professionals to perform general purpose surgical procedures. Some of the surgical instruments included in the device are invasive devices intended for transient use in the oral cavity and do not contain any pharmaceuticals. All the components in the sterile pack are class IIa or class I medical devices.

Authorization status:

A

Authorization date:

2014-03-13

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