FDA device listing

ADVANTIME

FDA device listing 1929963818 · PETERS SURGICAL INTERNATIONAL CO., Ltd

Key facts

Proprietary names ADVANTIME
Owner/operator PETERS SURGICAL INTERNATIONAL CO., Ltd
Owner/operator number 10054417
Product codes GAM
Device names GAM - Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class Class II
Classification regulations (21 CFR) 878.4493
Review panels General & Plastic Surgery
Registered establishments PETERS SURGICAL INTERNATIONAL CO., LTD
Establishment registrations 3013548553
FEI numbers 3013548553
Establishment operations Contract Manufacturer, Contract Sterilizer
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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