FDA device listing

Roosin Xeroform Petrolatum Dressing

FDA device listing 1676881108 · Hubei V-Medical Products Co., Ltd.

Key facts

Proprietary names Roosin Xeroform Petrolatum Dressing
Owner/operator Hubei V-Medical Products Co., Ltd.
Owner/operator number 10056239
Premarket submissions K181478
Product codes FRO
Device names FRO - Dressing, Wound, Drug
Device class Unclassified
Classification regulations (21 CFR) ORCA1.FRO
Review panels General & Plastic Surgery
Registered establishments HUBEI V-MEDICAL PRODUCTS CO., LTD.
Establishment registrations 3014146451
FEI numbers 3014146451
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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