Identity
- Trade Name
- SPROTTE® FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- SPROTTE® 25G x 1 3/8" (35mm), sterile FDA UDI
- Model / Reference
- 001151-29E FDA UDI
- Description
- SPROTTE® 25G x 1 3/8" (35mm), sterile FDA UDI
Identifiers
- Catalog Number
- 001151-29E FDA UDI
- Primary DI / UDI-DI
- 14048223017842 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
- 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
Yes
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
MR Unsafe FDA UDI
Sprotte® 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 d4fb812f-9688-4191-8134-2bd072a2ecec 36 fields · synced May 31, 2026