Identity
- Trade Name
- NRG Large Access Solution FDA UDI
- Generic Name
- Cardiac transseptal access set FDA UDI
- Device Name
- 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip Guidewire); 1 x ProTrack Pigtail Wire FDA UDI
- Model / Reference
- NLK-71-C0-125-67-18 FDA UDI
- Description
- 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip Guidewire); 1 x ProTrack Pigtail Wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00685447015345 FDA UDI
- FDA Product Code
- DXF FDA UDIDRE FDA UDI
- GMDN Term
- Cardiac transseptal access set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5175 FDA UDI870.1310 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 Large Access Solution 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 4ca061ee-26a5-49b1-9237-7187d557d1eb 36 fields · synced Jun 1, 2026