Identity
- Trade Name
- OsteoCool™ RF Ablation System FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- PUMP UNIT OC02-R OSTEOCOOL RF REFURBISH FDA UDI
- Model / Reference
- OC02-R FDA UDI
- Description
- PUMP UNIT OC02-R OSTEOCOOL RF REFURBISH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169674714 FDA UDI
- 510(k) Number
- K152057 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Percutaneous radio-frequency ablation system generator
OsteoCool™ RF Ablation System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Percutaneous radio-frequency ablation system generator.
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- InSeal Sealer/Divider — Innolcon Medical Technology (Suzhou) Co., Ltd. · Class IIb
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Cleared under the same submission
K152057 also covers:
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 56895632-a5be-4977-91fc-b374164f3c36 35 fields · synced Jun 1, 2026