FDA device listing

SDP COTTON BALL,SDP COTTON PAD,SDP COTTON ROLL,SDP CYLINDRICAL ROLL,SDP CYLINDRICAL SPONGE,SDP DENTAL PACKING,SDP DENTAL…

FDA device listing 1223459142 · SDP Inc.

Key facts

Proprietary names SDP COTTON BALL,SDP COTTON PAD,SDP COTTON ROLL,SDP CYLINDRICAL ROLL,SDP CYLINDRICAL SPONGE,SDP DENTAL PACKING,SDP DENTAL SPONGE,SDP ENT PACKING,SDP FLUFF BANDAGE,SDP FLUFF GAUZE,SDP GAUZE,SDP GAUZE DRESSING,SDP GAUZE PACKING,SDP GAUZE SPONGE,SDP NASAL PACKING,SDP NASAL PLUGS,SDP ROUND SPONGE,SDP STICK SPONGE,SDP THROAT PACKING,SDP TRACHEOSTOMY SPONGE,SDP VAGINAL PACKING
Owner/operator SDP Inc.
Owner/operator number 10052289
Product codes NAC
Device names NAC - Dressing, Wound, Hydrophilic
Device class Class I
Classification regulations (21 CFR) 878.4018
Review panels General & Plastic Surgery
Registered establishments SDP INC.
Establishment registrations 3012660022
FEI numbers 3012660022
Establishment operations Complaint File Establishment, Specification Developer
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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