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TGS Navigation

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
TGS Navigation FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
Electromagnetic Navigation Unit FDA UDI
Model / Reference
8000-010-003 FDA UDI
Description
Electromagnetic Navigation Unit FDA UDI

Identifiers

Catalog Number
8000-010-003 FDA UDI
Primary DI / UDI-DI
07613327413083 FDA UDI
FDA Product Code
PGW FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking 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

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
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic surgical navigation device tracking system

TGS Navigation by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 6a3e2f5d-5f18-436e-b146-ace0703c5187 36 fields · synced May 30, 2026