Identity
- Trade Name
- SONOPLEX FDA UDI
- Generic Name
- Nerve-locating anaesthesia needle FDA UDI
- Device Name
- NanoLineCornerStonesProximal End: ISO 80369-7 FDA UDI
- Model / Reference
- 001185-77 FDA UDI
- Description
- NanoLineCornerStonesProximal End: ISO 80369-7 FDA UDI
Identifiers
- Catalog Number
- 001185-77 FDA UDI
- Primary DI / UDI-DI
- 04048223103494 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
- 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 — 0.8 Millimeter FDA UDILength — 100.0 Millimeter FDA UDI
Category: Nerve-locating anaesthesia needle
Sonoplex by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve-locating anaesthesia needle.
- NeuroTrace — Neo Medical Inc. · Class II
- NeuroTrace — Neo Medical Inc. · Class II
- NeuroTrace — Neo Medical Inc. · Class II
- NeuroTrace — Neo Medical Inc. · Class II
- NeuroTrace — Neo Medical Inc. · Class II
- NeuroTrace — Neo Medical Inc. · Class II
- Stimuplex® — B. BRAUN MEDICAL INC. · Class II
- NeuroTrace — Neo Medical Inc. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 9c79acb5-c4d7-4d6d-97ef-23b7ecbfe567 37 fields · synced Jun 8, 2026