Entrant™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Entrant™ FDA UDI
Generic Name: Dual-chamber implantable defibrillator FDA UDI
Device Name: DR Implantable Cardioverter Defibrillator VVED DDDR FDA UDI
Model / Reference: CDDRA300Q FDA UDI
Description: DR Implantable Cardioverter Defibrillator VVED DDDR FDA UDI

Identifiers

Catalog Number: CDDRA300Q FDA UDI
Primary DI / UDI-DI: 05415067032843 FDA UDI
FDA Product Code: OSR 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dual-chamber implantable defibrillator

Entrant™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dual-chamber implantable defibrillator.

ORIGEN™ EL ICD DR — Boston Scientific · Class III
Acticor 7 DR-T DF4 ProMRI — BIOTRONIK SE & Co. KG · Class III
INOGEN™ EL ICD DR — Boston Scientific · Class III
INCEPTA™ CRT-D — Boston Scientific · Class III
INOGEN™ EL ICD DR — Boston Scientific · Class III
Cobalt™ XT DR MRI SureScan™ — MEDTRONIC, INC. · Class III
INCEPTA™ CRT-D — Boston Scientific · Class III
Crome™ DR MRI SureScan™ — MEDTRONIC, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 168a6ff7-4220-4dde-aad0-546b72981dcc 36 fields · synced Jun 8, 2026