Identity
- Trade Name
- SemiCut FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- 10 CS-SEMIAUTOM. GUILLOTINE NEEDLE 20G X 70mm FOR SOFT TISSUES BIOPSY WITHOUT REMOVABLE LUER FDA UDI
- Model / Reference
- PD02007 FDA UDI
- Description
- 10 CS-SEMIAUTOM. GUILLOTINE NEEDLE 20G X 70mm FOR SOFT TISSUES BIOPSY WITHOUT REMOVABLE LUER FDA UDI
Identifiers
- Catalog Number
- PD02007 FDA UDI
- Primary DI / UDI-DI
- 08032986357917 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
- Needle Gauge — 20 Gauge FDA UDILength — 70 Millimeter 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
K160316 also covers:
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 32f6867e-1bf3-4eb8-9fb9-b047d32d3097 37 fields · synced May 31, 2026