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Distal Radius Sterile Kit (Sterile) - PMDA ID 340216_23000BZX00299000_A_01_02

Distal Radius Sterile Kit(滅菌)

Access comprehensive regulatory information for Distal Radius Sterile Kit (Sterile) (Distal Radius Sterile Kit(滅菌)) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 340216_23000BZX00299000_A_01_02 and manufactured by Johnson & Johnson K.K.. The device information was last updated on July 08, 2022.

This page provides complete registration details including device class (B0400), classification (internal fixation plate / 体内固定用プレート), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.

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PMDA Official Data
Bilingual (EN/JP)
MD
B0400
340216_23000BZX00299000_A_01_02
MD
B0400
Distal Radius Sterile Kit (Sterile)
Distal Radius Sterile Kit(滅菌)
PMDA ID: 340216_23000BZX00299000_A_01_02
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Intended Use / 使用目的
English

This product is used for reduction fixation for distal radius fractures and corrective osteotomies. In order to improve convenience during surgery, necessary medical equipment is provided in a pre-combined state. This product is for single use.

日本語 (Japanese)

本品は、橈骨遠位部骨折、同矯正骨切り術に対する整復固定に用いる。手術時の利便性向上のため、必要な医療機器を予め組み合わせた状態で供される。本品は単回使用である。

Device Classification / 分類
Device Type
MD
Device Class
B0400
Class Name (English)
internal fixation plate
Class Name (日本語)
体内固定用プレート
Registration Information / 登録情報
PMDA ID
340216_23000BZX00299000_A_01_02
Last Update Date
July 08, 2022
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/ジョンソン・エンド・ジョンソン株式会社
Product Names / 製品名
Market Name (English)
Distal Radius Sterile Kit (Sterile)
Market Name (日本語)
Distal Radius Sterile Kit(滅菌)