PMDA device listing

gSource骨鉗子(1312)

PMDA Medical device listing · 13B1X00170000119 · Class I

Key facts

PMDA document key 100607_13B1X00170000119_A_01
Brand names gSource骨鉗子(1312)
General names (JMDN) 手術用骨鉗子
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00170000119
JMDN codes 32853000
Category code A3900
Marketing authorization holder 製造販売/株式会社アムテック
Package insert date Jul 29, 2021
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

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