Identity
- Trade Name
- PrimoCut FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- PrimoCut 18G (1,2) x 280mm sterile FDA UDI
- Model / Reference
- 415S120280 FDA UDI
- Description
- PrimoCut 18G (1,2) x 280mm sterile FDA UDI
Identifiers
- Catalog Number
- 415S120280 FDA UDI
- Primary DI / UDI-DI
- 04048223087299 FDA UDI
- FDA Product Code
- MJG FDA UDI
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Dimensions & Sizes
- Size
- Length — 280.0 Millimeter FDA UDINeedle Gauge — 18.0 Gauge FDA UDI
Category: Side-notch biopsy gun handpiece/needle
PrimoCut by Pajunk GmbH Medizintechnologie — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Side-notch biopsy gun handpiece/needle.
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- MONOPTY — Bard Peripheral Vascular · Class II
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- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 4db6a154-117f-4f17-b385-8817c137543f 37 fields · synced Jun 8, 2026