IS4/DF4 Adapter

FDA UDI

Class III (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name: IS4/DF4 Adapter FDA UDI
Generic Name: Pacing/defibrillation lead repair kit FDA UDI
Model / Reference: 412303 FDA UDI

Identifiers

Catalog Number: 412303 FDA UDI
Primary DI / UDI-DI: 04035479150266 FDA UDI
PMA Number: P980023 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

IS4/DF4 Adapter by BIOTRONIK SE & Co. KG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pacing/defibrillation lead repair kit.

REF 7001 EZ-4™ Connector Tool — Boston Scientific · Class III
Model 4625 ACUITY® X4 Connector Tool — Boston Scientific · Class III
SJM™ — ST. JUDE MEDICAL, INC. · Class III
IS4/DF4 Adapter — BIOTRONIK SE & Co. KG · Class III

Cleared under the same submission

P980023 also covers:

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: BIOTRONIK SE & Co. KG

Sources (1)

FDA UDI 5b3d0c11-9e50-4e2e-8b33-ee25136bfe25 36 fields · synced May 30, 2026