Identity
- Trade Name
- Evoke® Closed-Loop Stimulator (CLS) FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
- Model / Reference
- 3042 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09352307001572 FDA UDI
- PMA Number
- P190002 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Evoke® Closed-Loop Stimulator (CLS) by Saluda Medical Pty Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable.
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
- PNS Freedom-8A Permanent Neurostimulator Spare Kit Channel A — Curonix · Class II
- Proclaim™ — ST. JUDE MEDICAL, INC. · Class III
- Vanta™ AdaptiveStim™ — MEDTRONIC, INC. · Class III
- Altius IPG — Neuros Medical, Inc. · Class III
- Precision™ Montage™ MRI — Boston Scientific Neuromodulation · Class III
- Freedom System Accessory — Curonix · Class II
Cleared under the same submission
P190002 also covers:
- Evoke ® CAP12 Percutaneous Lead Kit - 60 cm — SALUDA MEDICAL PTY LIMITED
- Evoke® 12C Lead Extension Kit - 55cm — SALUDA MEDICAL PTY LIMITED
- Evoke® 12C Percutaneous Lead Kit - 60 cm — SALUDA MEDICAL PTY LIMITED
- Evoke® 12C Percutaneous Lead Kit - 90 cm — SALUDA MEDICAL PTY LIMITED
- Evoke® 12C Percutaneous Trial Lead Kit - 60 cm — SALUDA MEDICAL PTY LIMITED
- Evoke® 12C Percutaneous Trial Lead Kit - 90 cm — SALUDA MEDICAL PTY LIMITED
- Evoke® Accessory Belt — SALUDA MEDICAL PTY LIMITED
- Evoke® Active Anchor Kit — SALUDA MEDICAL PTY LIMITED
- Evoke® Active Anchor Kit — SALUDA MEDICAL PTY LIMITED
- Evoke® Active Anchor Kit - L — SALUDA MEDICAL PTY LIMITED
- Evoke® CAP12 Percutaneous Lead Kit - 60 cm — SALUDA MEDICAL PTY LIMITED
- Evoke® CAP12 Percutaneous Lead Kit - 60 cm — SALUDA MEDICAL PTY LIMITED
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Saluda Medical Pty Limited
Sources (1)
- FDA UDI d56aaf11-9acc-4568-8d3e-49a1b10430f0 33 fields · synced Jun 1, 2026