FDA device listing

INSTRUMENTARIUM

FDA device listing 1377804059 · INSTRUMENTARIUM SURGICAL CORP., INC.

Key facts

Proprietary names INSTRUMENTARIUM
Owner/operator INSTRUMENTARIUM SURGICAL CORP., INC.
Owner/operator number 9041885
Product codes MJG
Device names MJG - Device, Percutaneous, Biopsy
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments INSTRUMENTARIUM SURGICAL CORP., INC.
Establishment registrations 9615857
FEI numbers 3002409980
Establishment operations Repackager/Relabeler
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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