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ReActiv8 Stimulation Lead

FDA UDI

Class III (US FDA UDI)

by Mainstay Medical Limited

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, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc. FDA UDI
Model / Reference
7M8165-006 FDA UDI
Description
Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc. FDA UDI

Identifiers

Catalog Number
8165 FDA UDI
Primary DI / UDI-DI
05391527772279 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
Not 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
MRI Safety
MR Unsafe FDA UDI

ReActiv8 Stimulation Lead by Mainstay Medical Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P190021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mainstay Medical Limited

Sources (1)

  • FDA UDI 19b21841-c4c3-43ff-b018-6418b4ab70a5 37 fields · synced Jun 6, 2026