FDA device listing

Carboxymethyl hemostatic gauze; Chitosan hemostiatic gauze,ECURA Soluble Hemostatic Gauze, Dental; Pack,ECURA Soluble…

FDA device listing 1248282555 · EON CUREMED PRIVATE LIMITED

Key facts

Proprietary names Carboxymethyl hemostatic gauze; Chitosan hemostiatic gauze,ECURA Soluble Hemostatic Gauze, Dental; Pack,ECURA Soluble Hemostatic Gauze, Dental; Pack (4 layers),ECURA Soluble Hemostatic Gauze, Dental; Roll,ECURA Soluble Hemostatic Gauze, General; Pack,ECURA Soluble Hemostatic Gauze, General; Pack (4 layers),ECURA Soluble Hemostatic Gauze, General; Roll,ECURA Soluble Hemostatic Gauze, Taruma; Type…
Owner/operator EON CUREMED PRIVATE LIMITED
Owner/operator number 10094444
Product codes NAB
Device names NAB - Gauze / Sponge,Nonresorbable For External Use
Device class Class I
Classification regulations (21 CFR) 878.4014
Review panels General & Plastic Surgery
Registered establishments EON CUREMED PRIVATE LIMITED
Establishment registrations 3042972928
FEI numbers 3042972928
Establishment operations Complaint File Establishment, 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

Browse all FDA device listings