FDA device listing

RM0112 re.markable

FDA device listing 2069860631 · STRYKER CORP.

Key facts

Proprietary names RM0112 re.markable
Owner/operator STRYKER CORP.
Owner/operator number 1811755
Product codes PTQ
Device names PTQ - Endoscopic Magnetic Retriever, Exempt
Device class Class II
Classification regulations (21 CFR) 876.1500
Review panels Gastroenterology & Urology
Registered establishments Stryker Endoscopy, STRYKER ENDOSCOPY
Establishment registrations 2936485, 3015439135
FEI numbers 2936485, 3015439135
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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