Identity
- Trade Name
- Biosense Webster FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, reprocessed FDA UDI
- Model / Reference
- D134906 FDA UDI
Identifiers
- Catalog Number
- D134906 FDA UDI
- Primary DI / UDI-DI
- 07613327361995 FDA UDI
- 510(k) Number
- K112292 FDA UDI
- FDA Product Code
- NLH FDA UDI
- GMDN Term
- Cardiac mapping catheter, percutaneous, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 115.0 Centimeter FDA UDI
Biosense Webster by Stryker Sustainability Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Sustainability Solutions
Sources (1)
- FDA UDI 71b4180c-eb68-4c81-8621-d16c50a89186 37 fields · synced May 30, 2026