FDA device listing

Gauge, Depth

FDA device listing 1021172720 · CREATEC LTD. & CO. KG

Key facts

Owner/operator CREATEC LTD. & CO. KG
Owner/operator number 9099162
Product codes HTJ
Device names HTJ - Gauge, Depth
Device class Class I
Classification regulations (21 CFR) 888.4300
Review panels Orthopedic
Registered establishments CREATEC GmbH & CO. KG
Establishment registrations 3006694268
FEI numbers 3006694268
Establishment operations Contract Manufacturer, Foreign Exporter
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

Browse all FDA device listings