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Guidance handpiece

FDA UDI

Class II (US FDA UDI)

by Halt Medical, Inc

Identity

Trade Name
Guidance handpiece FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
Disposable handpiece connects to generator FDA UDI
Model / Reference
5300 FDA UDI
Description
Disposable handpiece connects to generator FDA UDI

Identifiers

Catalog Number
5300 FDA UDI
Primary DI / UDI-DI
00854763006089 FDA UDI
FDA Product Code
HFG FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4160 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: Electromagnetic surgical navigation device tracking system

Guidance handpiece by Halt Medical, Inc — 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
Halt Medical, Inc

Sources (1)

  • FDA UDI e9ef58f0-dbff-4d4a-9bcb-384bdae2c747 34 fields · synced Jun 8, 2026