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Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter for Medline Renewal FDA UDI
- Model / Reference
- 85900PRH FDA UDI
- Description
- Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter for Medline Renewal FDA UDI
Identifiers
- Catalog Number
- 85900PRH FDA UDI
- Primary DI / UDI-DI
- 00850065047041 FDA UDI
- 510(k) Number
- K232584 FDA UDI
- FDA Product Code
- OWQ FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravascular ultrasound imaging catheter, reprocessed
Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter by Vein 360, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intravascular ultrasound imaging catheter, reprocessed.
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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
- Vein 360, LLC
Sources (1)
- FDA UDI dcfce050-f58a-4450-b4bb-9fc8919a8011 35 fields · synced Jun 8, 2026