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OsteoCool™ RF Ablation System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
OsteoCool™ RF Ablation System FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI
Device Name
PROBE KIT OCP110 OSTEOCOOL RF 17G 10MM FDA UDI
Model / Reference
OCP110 FDA UDI
Description
PROBE KIT OCP110 OSTEOCOOL RF 17G 10MM FDA UDI

Identifiers

Primary DI / UDI-DI
00643169546226 FDA UDI
510(k) Number
K152057 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar

OsteoCool™ RF Ablation System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar.

Cleared under the same submission

K152057 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 2dbb1a44-edb3-47ca-8b3c-35bf9b4f45f6 35 fields · synced Jun 7, 2026