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Tac-S

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
TAC-S FDA UDI
Generic Name
Endoscopic surgical probe FDA UDI
Device Name
TAC -S MICRO VULCAN INTEGRATED FDA UDI
Model / Reference
7209631 FDA UDI
Description
TAC -S MICRO VULCAN INTEGRATED FDA UDI

Identifiers

Catalog Number
7209631 FDA UDI
Primary DI / UDI-DI
03596010470621 FDA UDI
510(k) Number
K003198 FDA UDI
FDA Product Code
HRX FDA UDI
GEI FDA UDI
GMDN Term
Endoscopic surgical probe 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: Endoscopic surgical probe

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

Similar devices

Also classified as Endoscopic surgical probe.

Cleared under the same submission

K003198 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 67db4992-0aeb-4937-9fe6-a92c48875ca6 36 fields · synced Jun 8, 2026