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Revo MRI™ SureScan™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Revo MRI™ SureScan™ FDA UDI
Generic Name
Dual-chamber implantable pacemaker, rate-responsive FDA UDI
Device Name
IPG RVDR01 REVO MRI SURESCAN US MKT IS-1 FDA UDI
Model / Reference
RVDR01 FDA UDI
Description
IPG RVDR01 REVO MRI SURESCAN US MKT IS-1 FDA UDI

Identifiers

Primary DI / UDI-DI
00613994614742 FDA UDI
PMA Number
P090013 FDA UDI
FDA Product Code
NVZ FDA UDI
LWP FDA UDI
GMDN Term
Dual-chamber implantable pacemaker, rate-responsive FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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 Conditional FDA UDI

Category: Dual-chamber implantable pacemaker, rate-responsive

Revo MRI™ SureScan™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dual-chamber implantable pacemaker, rate-responsive.

Cleared under the same submission

P090013 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 369d6e37-f47b-45c3-9130-f3f394b76268 36 fields · synced May 30, 2026