INTELLAGEN™ Tubing Set 40 PK

FDA UDI

Class III (US FDA UDI)

by Stockert GmbH

Identity

Trade Name: INTELLAGEN™ Tubing Set 40 PK FDA UDI
Generic Name: Cardiac ablation system irrigation tubing set FDA UDI
Device Name: Shipping box carton containing 4 boxes of 10 individual devices; Not commercialized FDA UDI
Model / Reference: 20624 FDA UDI
Description: Shipping box carton containing 4 boxes of 10 individual devices; Not commercialized FDA UDI

Identifiers

Catalog Number: M004GEN100206241 FDA UDI
Primary DI / UDI-DI: 04260166374360 FDA UDI
FDA Product Code: OAD FDA UDI
GMDN Term: Cardiac ablation system irrigation tubing set 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

Yes

FDA UDI

Category: Cardiac ablation system irrigation tubing set

INTELLAGEN™ Tubing Set 40 PK by Stockert GmbH — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Stockert GmbH

Sources (1)

FDA UDI 4ea1506a-c878-420d-b1d0-b8e6f6c351e6 36 fields · synced May 30, 2026