Identity
- Trade Name
- SPRINT™ FDA UDI
- Generic Name
- Analgesic PENS system FDA UDI
- Device Name
- Single Procedure Kit w/ Pad I FDA UDI
- Model / Reference
- PNS System FDA UDI
- Description
- Single Procedure Kit w/ Pad I FDA UDI
Identifiers
- Catalog Number
- 9243 FDA UDI
- Primary DI / UDI-DI
- 00854001007366 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Analgesic PENS system
Sprint™ by Spr Therapeutics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Analgesic PENS system.
- BiowavePRO — BioWave Corporation · Class II
- StimTrial Surgical Kit — BIOVENTUS LLC · Class II
- SPRINT — SPR THERAPEUTICS, INC · Class II
- SPRINT — SPR THERAPEUTICS, INC · Class II
- SPRINT™ — SPR THERAPEUTICS, INC · Class II
- SPRINT — SPR THERAPEUTICS, INC · Class II
- SPRINT — SPR THERAPEUTICS, INC · Class II
- SPRINT — SPR THERAPEUTICS, INC · Class II
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 0e012d73-98af-45a6-a143-a9f7f2784ac2 35 fields · synced Jun 8, 2026