Identity
- Trade Name
- UNIPLEX® NANOLINE FDA UDI
- Generic Name
- Nerve-locating anaesthesia needle FDA UDI
- Device Name
- Proximal End: ISO 80369-7 NanoLine FDA UDI
- Model / Reference
- 001156-70 FDA UDI
- Description
- Proximal End: ISO 80369-7 NanoLine FDA UDI
Identifiers
- Catalog Number
- 001156-70 FDA UDI
- Primary DI / UDI-DI
- 04048223102527 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Nerve-locating anaesthesia needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.7 Millimeter FDA UDILength — 40.0 Millimeter FDA UDI
Uniplex® Nanoline by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 726328c6-9aef-4c3b-8edd-2f8f9a38a2c4 38 fields · synced May 31, 2026