Identity
- Trade Name
- InfiltraLong Sono FDA UDI
- Generic Name
- Peripheral anaesthesia catheter set, non-medicated FDA UDI
- Device Name
- InfiltraLong Sono Tuohy Sono needle 17G x 90mm with Cornerstone reflectors, FDA UDI
- Model / Reference
- 001185-20B FDA UDI
- Description
- InfiltraLong Sono Tuohy Sono needle 17G x 90mm with Cornerstone reflectors, FDA UDI
Identifiers
- Catalog Number
- 001185-20B FDA UDI
- Primary DI / UDI-DI
- 04048223131053 FDA UDI
- 510(k) Number
- K080675 FDA UDI
- FDA Product Code
- BSO FDA UDI
- GMDN Term
- Peripheral anaesthesia catheter set, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5120 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
InfiltraLong Sono by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080675 also covers:
- InfiltraLong — Pajunk GmbH Medizintechnologie
- InfiltraLong — Pajunk GmbH Medizintechnologie
- InfiltraLong — Pajunk GmbH Medizintechnologie
- InfiltraLong 420 — Pajunk GmbH Medizintechnologie
- InfiltraLong 500 — Pajunk GmbH Medizintechnologie
- InfiltraLong 500T — Pajunk GmbH Medizintechnologie
- InfiltraLong 600 — Pajunk GmbH Medizintechnologie
- InfiltraLong 600T — Pajunk GmbH Medizintechnologie
- InfiltraLong 600T — Pajunk GmbH Medizintechnologie
- InfiltraLong 700 — Pajunk GmbH Medizintechnologie
- InfiltraLong 900 — 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 |
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Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 162a0e2f-bc00-4c4f-83ef-d6d4f31bcbb6 37 fields · synced Jun 6, 2026