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iGUIDE

FDA UDI

Class II (US FDA UDI)

by 3C-Medical Intelligence GmbH

Identity

Trade Name
iGUIDE FDA UDI
Generic Name
Accelerator system table, powered FDA UDI
Device Name
iGUIDE Reference Frame Set used by iGUIDE Software to control position of HexaPOD evo FDA UDI
Model / Reference
P10602-131 FDA UDI
Description
iGUIDE Reference Frame Set used by iGUIDE Software to control position of HexaPOD evo FDA UDI

Identifiers

Catalog Number
P10602-131 FDA UDI
Primary DI / UDI-DI
04056719001674 FDA UDI
510(k) Number
K143485 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Accelerator system table, powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

Category: Accelerator system table, powered

iGUIDE by 3C-Medical Intelligence GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Accelerator system table, powered.

Cleared under the same submission

K143485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3C-Medical Intelligence GmbH

Sources (1)

  • FDA UDI b2a1dd10-b1b0-4d28-b2f2-431b7550da48 35 fields · synced May 30, 2026