Identity
- Trade Name
- Philips Healthcare FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Model / Reference
- 014R FDA UDI
Identifiers
- Catalog Number
- 014R FDA UDI
- Primary DI / UDI-DI
- 07613327664089 FDA UDI
- 510(k) Number
- K200195 FDA UDI
- FDA Product Code
- OWB FDA UDIOWQ FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI870.1200 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravascular ultrasound imaging catheter, reprocessed
Philips Healthcare by Stryker Sustainability Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Stryker Sustainability Solutions
Sources (1)
- FDA UDI c86ab68e-56de-4d12-a666-a8589c06a11d 35 fields · synced Jun 8, 2026