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NES Reprocessed Eagle Eye Platinum Long Tip Stryker
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- NES Reprocessed Eagle Eye Platinum Long Tip Stryker FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- NES Reprocessed Eagle Eye Platinum Long Tip Catheter manufactured for Stryker (SSS) FDA UDI
- Model / Reference
- R-S85900P FDA UDI
- Description
- NES Reprocessed Eagle Eye Platinum Long Tip Catheter manufactured for Stryker (SSS) FDA UDI
Identifiers
- Catalog Number
- R-S85900P FDA UDI
- Primary DI / UDI-DI
- B227RS85900P1 FDA UDI
- 510(k) Number
- K223026 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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 150 Centimeter FDA UDIGuidewire Diameter — 0.014 Inch FDA UDIIntroducer Sheath Compatibility — 5 French FDA UDI
Category: Intravascular ultrasound imaging catheter, reprocessed
NES Reprocessed Eagle Eye Platinum Long Tip Stryker by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular ultrasound imaging catheter, reprocessed.
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Vein360 Reprocessed Visions PV.014P RX Digitial IVUS Catheter (014P) — Vein 360, LLC · Class II
- Philips Healthcare — Stryker Sustainability Solutions · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter — Vein 360, LLC · Class II
- Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter — Vein 360, LLC · Class II
- Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (014R) — Vein 360, LLC · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K223026 also covers:
- NES Reprocessed .014 Stryker Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Eagle Eye Platinum Long Tip Stryker — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip — NORTHEAST SCIENTIFIC, INC.
- NES Reprocessed Eagle Eye Platinum Short Tip Stryker — NORTHEAST SCIENTIFIC, INC.
- Philips Healthcare — Stryker Sustainability Solutions
- Philips Healthcare — Stryker Sustainability Solutions
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
- Northeast Scientific, Inc.
Sources (1)
- FDA UDI 7dafdab2-80f5-4e0f-9611-aef04ad08c75 38 fields · synced Jun 6, 2026