Crome™ DR MRI SureScan™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Crome™ DR MRI SureScan™ FDA UDI
Generic Name: Dual-chamber implantable defibrillator FDA UDI
Device Name: ICD DDPC3D1 CROME DR MRI DF1 USA FDA UDI
Model / Reference: DDPC3D1 FDA UDI
Description: ICD DDPC3D1 CROME DR MRI DF1 USA FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000178413 FDA UDI
FDA Product Code: NVZ FDA UDI
LWS FDA UDI
GMDN Term: Dual-chamber implantable defibrillator 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dual-chamber implantable defibrillator

Crome™ DR 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 defibrillator.

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INOGEN™ EL ICD DR — Boston Scientific · Class III
Fortify Assura™ — ST. JUDE MEDICAL, INC. · Class III
Current™ — ST. JUDE MEDICAL, INC. · Class III
Entrant™ — ST. JUDE MEDICAL, INC. · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI 062ed228-fceb-4fa9-bfb3-2cbc23f5cb91 35 fields · synced Jun 8, 2026