FDA device listing

GRAVES VAGINAL SPECULUM

FDA device listing 1654957306 · ASUAHWAE LLC

Key facts

Proprietary names GRAVES VAGINAL SPECULUM
Owner/operator ASUAHWAE LLC
Owner/operator number 9078200
Product codes HDF
Device names HDF - Speculum, Vaginal, Metal
Device class Class I
Classification regulations (21 CFR) 884.4520
Review panels Obstetrics/Gynecology
Registered establishments Precision Medical Manufacturing LLC
Establishment registrations 1416666
FEI numbers 1416666
Establishment operations Contract Manufacturer, 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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