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Nimbus Probe (Disposable)

FDA UDI

Class II (US FDA UDI)

by Stratus Medical LLC

Identity

Trade Name
Nimbus Probe (Disposable) FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI
Device Name
Disposable RF Thermocouple Electrode FDA UDI
Model / Reference
NDP-100-27-SS FDA UDI
Description
Disposable RF Thermocouple Electrode FDA UDI

Identifiers

Primary DI / UDI-DI
05060224332016 FDA UDI
510(k) Number
K090608 FDA UDI
FDA Product Code
GXI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4725 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

Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

Nimbus Probe (Disposable) by Stratus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use.

Cleared under the same submission

K090608 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stratus Medical LLC

Sources (1)

  • FDA UDI 0eeec744-f7af-44b0-a3e6-39f55128d216 35 fields · synced May 29, 2026