Identity
- Trade Name
- INTELLAGEN™ Tubing Set 10 PK FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Model / Reference
- 20625 FDA UDI
Identifiers
- Catalog Number
- M004GEN100206251 FDA UDI
- Primary DI / UDI-DI
- 04260166374353 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac ablation system irrigation tubing set
INTELLAGEN™ Tubing Set 10 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 c537f2ac-0fd4-402c-8338-f52ee9a2c779 35 fields · synced May 30, 2026