FDA device listing

ConMed 883590,SURELINE SKIN STAPLE EXTRACTOR

FDA device listing 1170593359 · DESIGN STANDARDS CORP.

Key facts

Proprietary names ConMed 883590,SURELINE SKIN STAPLE EXTRACTOR
Owner/operator DESIGN STANDARDS CORP.
Owner/operator number 1220100
Product codes GDT
Device names GDT - Staple, Removable (Skin)
Device class Class I
Classification regulations (21 CFR) 878.4760
Review panels General & Plastic Surgery
Registered establishments DESIGN STANDARDS CORP.
Establishment registrations 1222274
FEI numbers 1000121057
Establishment operations Contract 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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