Identity
- Trade Name
- IRVINE BIOMEDICAL INC. FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, reprocessed FDA UDI
- Device Name
- Steerable Diagnostic EP Catheter, 20mm(A-FOCUS), 20 electrodes, 1-2.5mm spacing, 7F FDA UDI
- Model / Reference
- D087024 FDA UDI
- Description
- Steerable Diagnostic EP Catheter, 20mm(A-FOCUS), 20 electrodes, 1-2.5mm spacing, 7F FDA UDI
Identifiers
- Catalog Number
- D087024 FDA UDI
- Primary DI / UDI-DI
- 07613327395969 FDA UDI
- 510(k) Number
- K112232 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 — 110.0 Centimeter FDA UDI
Irvine Biomedical Inc. by Stryker Sustainability Solutions — 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
- Stryker Sustainability Solutions
Sources (1)
- FDA UDI 2e1e8d8e-f1b9-4a1b-849a-dfa3774aff54 38 fields · synced May 29, 2026