Identity
- Trade Name
- ReActiv8 Stimulation Lead FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
- Device Name
- Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packaged at OI. FDA UDI
- Model / Reference
- 7M8165-005 FDA UDI
- Description
- Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packaged at OI. FDA UDI
Identifiers
- Catalog Number
- 8165 FDA UDI
- Primary DI / UDI-DI
- 05391527772262 FDA UDI
- PMA Number
- P190021 FDA UDI
- FDA Product Code
- QLK FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
ReActiv8 Stimulation Lead by Mainstay Medical Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Programmer — MAINSTAY MEDICAL LIMITED
- ReActiv8 Programming Wand — 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 d4802c5b-8111-4409-a9c2-65a4834cad0d 36 fields · synced Jun 8, 2026