Identity
- Trade Name
- ReActiv8 Programmer FDA UDI
- Generic Name
- Implantable electrical stimulation device management software FDA UDI
- Model / Reference
- 6M7500-011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391527771357 FDA UDI
- PMA Number
- P190021 FDA UDI
- FDA Product Code
- QLK FDA UDI
- GMDN Term
- Implantable electrical stimulation device management software 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Implantable electrical stimulation device management software
ReActiv8 Programmer by Mainstay Medical Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable electrical stimulation device management software.
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation · Class III
- SureTune™ 4 — MEDTRONIC, INC. · Class II
- Bionic Navigator™ — Boston Scientific Neuromodulation · Class III
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation · Class III
- Nalu Medical, Inc. — NALU MEDICAL · Class II
- SureTune™ 4 — MEDTRONIC, INC. · Class II
- Bionic Navigator™ 3D — Boston Scientific Neuromodulation · Class III
Cleared under the same submission
P190021 also covers:
- Mainstay Tunneler — MAINSTAY MEDICAL LIMITED
- ReActiv8 Activator — MAINSTAY MEDICAL LIMITED
- ReActiv8 IPG — MAINSTAY MEDICAL LIMITED
- ReActiv8 Magnet — MAINSTAY MEDICAL LIMITED
- ReActiv8 Programmer — MAINSTAY MEDICAL LIMITED
- ReActiv8 Programming Wand — MAINSTAY MEDICAL LIMITED
- ReActiv8 Stimulation Lead — MAINSTAY MEDICAL LIMITED
- ReActiv8 Stimulation Lead — MAINSTAY MEDICAL LIMITED
- ReActiv8 Torque Wrench — MAINSTAY MEDICAL 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 |
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Manufacturer
- Manufacturer
- Mainstay Medical Limited
Sources (1)
- FDA UDI fcdb19b0-b6de-47d0-9a90-2e9710cb7336 34 fields · synced May 30, 2026