Identity
- Trade Name
- SPRINT™ FDA UDI
- Generic Name
- Analgesic PENS system FDA UDI
- Device Name
- SPRINT™ MicroLead (20cm) and Introducer FDA UDI
- Model / Reference
- MicroLead (20cm) and Introducer FDA UDI
- Description
- SPRINT™ MicroLead (20cm) and Introducer FDA UDI
Identifiers
- Catalog Number
- 9144-CME FDA UDI
- Primary DI / UDI-DI
- 00854001007113 FDA UDI
- FDA Product Code
- NHI FDA UDI
- GMDN Term
- Analgesic PENS system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
No
FDA UDI
MR Unsafe FDA UDI
Sprint™ by Spr Therapeutics, Inc — 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
- Spr Therapeutics, Inc
Sources (1)
- FDA UDI 7c078e2a-ba9b-4325-97cb-a0d1ed72e381 36 fields · synced May 30, 2026