Identity
- Trade Name
- Themy FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- 5 CS- THEMY AUTOMATIC NEEDLE 16Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm FDA UDI
- Model / Reference
- TY1610 FDA UDI
- Description
- 5 CS- THEMY AUTOMATIC NEEDLE 16Gx100mm FOR SOFT TISSUE BIOPSY NOTCH OF 20 mm FDA UDI
Identifiers
- Catalog Number
- TY1610 FDA UDI
- Primary DI / UDI-DI
- 08052110100073 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 — 16 Gauge FDA UDI
Themy 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (1)
- FDA UDI f3bf6516-7d42-4d64-8971-c22acf403870 37 fields · synced Jun 1, 2026