FDA device listing

Orthopedic Needle Holder CHIRMED

FDA device listing 1406724056 · Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma

Key facts

Proprietary names Orthopedic Needle Holder CHIRMED
Owner/operator Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma
Owner/operator number 9023253
Product codes HXK
Device names HXK - Holder, Needle; Orthopedic
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa
Establishment registrations 3005587147
FEI numbers 3005587147
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

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

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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