FDA device listing

JM MEDICAL

FDA device listing 1198626220 · Shapes Secrets LLC

Key facts

Proprietary names JM MEDICAL
Owner/operator Shapes Secrets LLC
Owner/operator number 10092918
Product codes MDA
Device names MDA - Elastomer, Silicone, For Scar Management
Device class Class I
Classification regulations (21 CFR) 878.4025
Review panels General & Plastic Surgery
Registered establishments SHAPES SECRETS LLC
Establishment registrations 3036497112
FEI numbers 3036497112
Establishment operations Complaint File Establishment, Repackager/Relabeler
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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