Identity
- Trade Name
- Evoke® Clinical System Transceiver (CST) FDA UDI
- Generic Name
- Implantable spinal cord electrical stimulation system programmer FDA UDI
- Model / Reference
- 3004 FDA UDI
Identifiers
- Catalog Number
- 3004 FDA UDI
- Primary DI / UDI-DI
- 09352307000049 FDA UDI
- PMA Number
- P190002 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Implantable spinal cord electrical stimulation system programmer FDA UDI
Classification
- Device Class
- Class III 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Implantable spinal cord electrical stimulation system programmer
Evoke® Clinical System Transceiver (CST) by Saluda Medical Pty Limited — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Implantable spinal cord electrical stimulation system programmer.
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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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| 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 (2)
- FDA UDI 494b6ab2-8216-4c94-bc9b-1d0b5fa4b5fb 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026