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OptaBlate

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
OptaBlate FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI
Device Name
Curve 15mm Probe Single Kit FDA UDI
Model / Reference
9700115000 FDA UDI
Description
Curve 15mm Probe Single Kit FDA UDI

Identifiers

Catalog Number
9700-115-000 FDA UDI
Primary DI / UDI-DI
07613327601152 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

Yes

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

No

FDA UDI

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

OptaBlate by Stryker Corp. — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI cd53a5ab-174f-4862-bc11-53a489ae0b12 36 fields · synced Jun 8, 2026