Identity
- Trade Name
- SPROTTE® FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- SPROTTE® 24G x 6" (150mm),sterile, with Introducer 0,80 x 40mm FDA UDI
- Model / Reference
- 131151-30A FDA UDI
- Description
- SPROTTE® 24G x 6" (150mm),sterile, with Introducer 0,80 x 40mm FDA UDI
Identifiers
- Catalog Number
- 131151-30A FDA UDI
- Primary DI / UDI-DI
- 04048223130063 FDA UDI
- 510(k) Number
- K241953 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Spinal needle, single-use 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 150.0 Millimeter FDA UDIOuter Diameter — 0.55 Millimeter FDA UDI
Category: Spinal needle, single-use
Sprotte® 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
K241953 also covers:
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® — Pajunk GmbH Medizintechnologie
- SPROTTE® NRFit — Pajunk GmbH Medizintechnologie
- SPROTTE® NRFit — Pajunk GmbH Medizintechnologie
- SPROTTE® NRFit — Pajunk GmbH Medizintechnologie
- SPROTTE® NRFit — 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 20b3a9e8-9c80-4ed7-8256-6b90c121aba2 38 fields · synced May 30, 2026