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Tac-S/Eflex

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
TAC-S/EFLEX FDA UDI
Generic Name
Radio-frequency ablation system probe, reusable FDA UDI
Device Name
TAC-S E-FLEX VULCAN FDA UDI
Model / Reference
7209637 FDA UDI
Description
TAC-S E-FLEX VULCAN FDA UDI

Identifiers

Catalog Number
7209637 FDA UDI
Primary DI / UDI-DI
03596010470683 FDA UDI
510(k) Number
K990859 FDA UDI
FDA Product Code
HRX FDA UDI
GEI FDA UDI
GMDN Term
Radio-frequency ablation system probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radio-frequency ablation system probe, reusable

Tac-S/Eflex by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency ablation system probe, reusable.

Cleared under the same submission

K990859 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 0a8feea3-bdbe-4782-a6b3-84083db95ec0 36 fields · synced Jun 8, 2026