FDA device listing

Tungsten - Lead Syringe Shield, Lead Vial Shield

FDA device listing 2053506448 · Ebayga Radiation Shielding Technology (Shanghai) Co., Ltd

Key facts

Proprietary names Tungsten - Lead Syringe Shield, Lead Vial Shield
Owner/operator Ebayga Radiation Shielding Technology (Shanghai) Co., Ltd
Owner/operator number 10042016
Product codes IWR
Device names IWR - Holder, Syringe, Lead
Device class Class I
Classification regulations (21 CFR) 892.6500
Review panels Radiology
Registered establishments EBAYGA RADIATION SHIELDING TECHNOLOGY (SHANGHAI) CO., LTD
Establishment registrations 3010141508
FEI numbers 3010141508
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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