Identity
- Trade Name
- NRG RF Transseptal Kit FDA UDI
- Generic Name
- Cardiac transseptal access set FDA UDI
- Device Name
- 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 x Dispersive Electrode FDA UDI
- Model / Reference
- NTK-711-8590 FDA UDI
- Description
- 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 x Dispersive Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00685447004028 FDA UDI
- FDA Product Code
- DXF FDA UDIDQY FDA UDIDRE FDA UDIDYB FDA UDI
- GMDN Term
- Cardiac transseptal access set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5175 FDA UDI870.1250 FDA UDI870.1310 FDA UDI870.1340 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
NRG RF Transseptal Kit by Baylis Médicale Cie Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Baylis Médicale Cie Inc
Sources (1)
- FDA UDI 510fdb1c-c54d-4668-bbf7-b6818d4d66a6 36 fields · synced May 31, 2026