Identity
- Trade Name
- SemiCut FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- 10 CS -SEMIAUTOMATIC GUILLOTINE NEEDLE 18G X 100mm FOR SOFT TISSUES BIOPSY WITHOUT REMOVABLE LUER FDA UDI
- Model / Reference
- PD01810 FDA UDI
- Description
- 10 CS -SEMIAUTOMATIC GUILLOTINE NEEDLE 18G X 100mm FOR SOFT TISSUES BIOPSY WITHOUT REMOVABLE LUER FDA UDI
Identifiers
- Catalog Number
- PD01810 FDA UDI
- Primary DI / UDI-DI
- 08052440105823 FDA UDI
- 510(k) Number
- K160316 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- End-cut biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
SemiCut by M.d.l. S.r.l. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (1)
- FDA UDI cc4d0a8f-0ab9-4995-8146-5d232e025749 37 fields · synced Jun 1, 2026