← Back to catalogue

ReActiv8 Torque Wrench

FDA UDI

Class III (US FDA UDI)

by Mainstay Medical Limited

Identity

Trade Name
ReActiv8 Torque Wrench FDA UDI
Generic Name
Surgical torque wrench, reusable FDA UDI
Device Name
Torque Wrench (packaged as a standalone accessory) FDA UDI
Model / Reference
7M5500-002 FDA UDI
Description
Torque Wrench (packaged as a standalone accessory) FDA UDI

Identifiers

Catalog Number
5500 FDA UDI
Primary DI / UDI-DI
05391527770817 FDA UDI
PMA Number
P190021 FDA UDI
FDA Product Code
QLK FDA UDI
GMDN Term
Surgical torque wrench, reusable 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Surgical torque wrench, reusable

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

Similar devices

Also classified as Surgical torque wrench, reusable.

Cleared under the same submission

P190021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mainstay Medical Limited

Sources (1)

  • FDA UDI 63f80b45-bca5-4ae0-86d9-420eba6a4ad9 36 fields · synced Jun 1, 2026