FDA device listing

Scissors, Episiotomy & Parametrium [HBH & Zeppelin]

FDA device listing 1950553996 · COOPERSURGICAL, INC.

Key facts

Proprietary names Scissors, Episiotomy & Parametrium [HBH & Zeppelin]
Owner/operator COOPERSURGICAL, INC.
Owner/operator number 9002384
Product codes HDK
Device names HDK - Scissors, Episiotomy
Device class Class I
Classification regulations (21 CFR) 884.4520
Review panels Obstetrics/Gynecology
Registered establishments COOPERSURGICAL, INC., HBH MEDIZINTECHNIK GMBH
Establishment registrations 1216677, 8010251
FEI numbers 1216677, 3002895220
Establishment operations Manufacturer, 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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