Identity
- Trade Name
- SonoLong Curl Echo FDA UDI
- Generic Name
- Peripheral anaesthesia catheter set, non-medicated FDA UDI
- Device Name
- SonoLong Curl Echo SonoLong NanoLine® cannula 18G x 50mm with Tuohy tip and FDA UDI
- Model / Reference
- 531188-34C FDA UDI
- Description
- SonoLong Curl Echo SonoLong NanoLine® cannula 18G x 50mm with Tuohy tip and FDA UDI
Identifiers
- Catalog Number
- 531188-34C FDA UDI
- Primary DI / UDI-DI
- 04048223126516 FDA UDI
- 510(k) Number
- K113188 FDA UDI
- FDA Product Code
- CAZ FDA UDI
- GMDN Term
- Peripheral anaesthesia catheter set, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5140 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
Category: Peripheral anaesthesia catheter set, non-medicated
SonoLong Curl Echo by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral anaesthesia catheter set, non-medicated.
- AVANOS — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Halyard — Avanos Medical, Inc. · Class II
- ECHOBRIGHT* Insulated Echogenic Regional Block Needle — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- CONTIPLEX® — B. BRAUN MEDICAL INC. · Class II
Cleared under the same submission
K113188 also covers:
- PlexoLong Sono NanoLine® acc. Meier — Pajunk GmbH Medizintechnologie
- PlexoLong Sono NanoLine® acc. Meier — Pajunk GmbH Medizintechnologie
- SonoLong Curl Echo — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Echo NanoLine® NRFit — Pajunk GmbH Medizintechnologie
- SonoLong Sono NanoLine® — Pajunk GmbH Medizintechnologie
- SonoLong Sono NanoLine® — Pajunk GmbH Medizintechnologie
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 6e2f9a2d-6605-4640-bb9c-b24fb04afe48 37 fields · synced May 30, 2026