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Localite TMS Navigator TS

FDA UDI

Class II (US FDA UDI)

by LOCALITE GmbH

Identity

Trade Name
Localite TMS Navigator TS FDA UDI
Generic Name
Stereotactic neuronavigation/planning system FDA UDI
Model / Reference
Adhesive Pads, square-cut (90 Pcs.) FDA UDI

Identifiers

Catalog Number
12355 FDA UDI
Primary DI / UDI-DI
G076A012355A1 FDA UDI
510(k) Number
K223577 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Stereotactic neuronavigation/planning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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
MRI Safety
MR Safe FDA UDI

Category: Stereotactic neuronavigation/planning system

Localite TMS Navigator TS by LOCALITE GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic neuronavigation/planning system.

Cleared under the same submission

K223577 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LOCALITE GmbH

Sources (1)

  • FDA UDI 3ed2a88b-96e3-49e3-ae65-45b71ebbc7bf 34 fields · synced May 31, 2026