Identity
- Trade Name
- UNIVERSAL PLUS FDA UDI
- Generic Name
- Side-notch biopsy gun needle FDA UDI
- Device Name
- Soft tissue biopsy needle compatible with reusable biopsy system 18G x 200mm FDA UDI
- Model / Reference
- UP18200-00/M FDA UDI
- Description
- Soft tissue biopsy needle compatible with reusable biopsy system 18G x 200mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08059174748609 FDA UDI
- 510(k) Number
- K181803 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Side-notch biopsy gun needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Side-notch biopsy gun needle
Universal Plus by Medax Unipersonale Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Side-notch biopsy gun needle.
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- BIOCORE II MG — HISTO S.A. · Class I
- BIOCORE II TC — HISTO S.A. · Class I
- BIOCORE II BR — HISTO S.A. · Class I
- BIOCORE II — HISTO S.A. · Class I
- MAGNUM — Bard Peripheral Vascular · Class II
Cleared under the same submission
K181803 also covers:
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- CHIBA — Medax Unipersonale Srl
- FNA CHIBA — Medax Unipersonale Srl
- FNA CHIBA — Medax Unipersonale Srl
- FNA CHIBA — Medax Unipersonale Srl
- FNA FRANSEEN — Medax Unipersonale Srl
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
- Medax Unipersonale Srl
Sources (1)
- FDA UDI be0f6ff3-5852-4cf1-b669-f840bf69ca9c 34 fields · synced May 30, 2026