REF 7001 EZ-4™ Connector Tool

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name: REF 7001 EZ-4™ Connector Tool FDA UDI
Generic Name: Pacing/defibrillation lead repair kit FDA UDI
Device Name: Connector Tool FDA UDI
Model / Reference: 7001 FDA UDI
Description: Connector Tool FDA UDI

Identifiers

Primary DI / UDI-DI: 00802526474804 FDA UDI
PMA Number: P910073 FDA UDI
FDA Product Code: NVY FDA UDI
GMDN Term: Pacing/defibrillation lead repair kit 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pacing/defibrillation lead repair kit

REF 7001 EZ-4™ Connector Tool by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pacing/defibrillation lead repair kit.

IS4/DF4 Adapter — BIOTRONIK SE & Co. KG · Class III
IS4/DF4 Adapter — BIOTRONIK SE & Co. KG · Class III
SJM™ — ST. JUDE MEDICAL, INC. · Class III
Model 4625 ACUITY® X4 Connector Tool — Boston Scientific · Class III

Cleared under the same submission

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: Boston Scientific

Sources (1)

FDA UDI 9a6463fc-97aa-4e5c-b3c3-671d6716c5d7 34 fields · synced May 30, 2026