FDA device listing

BANDAGE, CAST, POP bandage, Casting bandage, Casting splint, Cast Paddings; Casting Tapes; Plaster Bandage; Stockinette

FDA device listing 1661931353 · New Pentastar Medical Products Co. Limited

Key facts

Proprietary names BANDAGE, CAST, POP bandage, Casting bandage, Casting splint, Cast Paddings; Casting Tapes; Plaster Bandage; Stockinette
Owner/operator New Pentastar Medical Products Co. Limited
Owner/operator number 10063374
Product codes ITG
Device names ITG - Bandage, Cast
Device class Class I
Classification regulations (21 CFR) 890.3025
Review panels Physical Medicine
Registered establishments JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD.
Establishment registrations 3015058854
FEI numbers 3015058854
Establishment operations Foreign Exporter
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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