FDA Device Establishments · JSON-LD · Markdown
FEI 3004749705 · Manufacture Medical Device · Status: Active
| FEI Number | 3004749705 |
|---|---|
| Owner / Operator | M.D.L. S.r.l. (#10047695) |
| Address | Via Tavani 1/a, Delebio (So) Sondrio, 23014, IT |
| Mandatory US Agent | Followell Compliance Consultants LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MJG |
| Regulation § (21 CFR) | 878.4800 |
| Proprietary names | FASTCUTM Disposable needle XXGxYYYmm for soft tissue biopsy compatible with Magnum Gun Bard; PALIUM NEEDLE Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium; FAST-CUT E Disposable needle XXGYYYmm for soft tissue biopsy compatible with automatic Promag 2.2 gun; EASYLOCK Modified Menghini needle, XXGxYYYmm for aspirated cytohistological biopsy; INTRO Coaxial introducer needle XXG for needles XXG; FASTCUTS Disposable needle XXGxYYYmm for soft tissue biopsy, compatible with automatic Sterylab Fastgun Gun; HANDCUT Disposable needle XXGxYYYmm for soft tissue biopsy with manual action; FASTCUT P Disposable needle XXGxYYYmm for soft tissue biopsy compatible automatic Promag Gun; PALIUM COAXIAL Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium with coaxial XXGxYYmm; FAST-CUT E Disp. needle XXGxYYYmm for soft tissue biopsy compatible with automatic Promag 2.2. gun with coaxial XXGxYYmm |
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