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RHYTHMIA HDx™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
RHYTHMIA HDx™ FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
Localization Generator FDA UDI
Model / Reference
M004RH20010 FDA UDI
Description
Localization Generator FDA UDI

Identifiers

Catalog Number
M004RH20010 FDA UDI
Primary DI / UDI-DI
08714729938736 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromagnetic surgical navigation device tracking system

RHYTHMIA HDx™ by Boston Scientific — 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
Boston Scientific

Sources (1)

  • FDA UDI 43206108-8755-45ed-a1c5-34071a9cce75 34 fields · synced May 29, 2026