Identity
- Trade Name
- SPROTTE® FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- Distal Tip: SPROTTE® Proximal End: ISO 80369-7 FDA UDI
- Model / Reference
- 021151-30F FDA UDI
- Description
- Distal Tip: SPROTTE® Proximal End: ISO 80369-7 FDA UDI
Identifiers
- Catalog Number
- 021151-30F FDA UDI
- Primary DI / UDI-DI
- 04048223052457 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
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
- Length — 50.0 Millimeter FDA UDIOuter Diameter — 0.55 Millimeter 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pajunk GmbH Medizintechnologie
Sources (1)
- FDA UDI 043781c6-ddc6-4b76-a92d-43a91e5bcdb9 38 fields · synced May 31, 2026