Identity
- Trade Name
- NES Reprocessed .014 Stryker Catheter FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- NES Reprocessed .014 IVUS Catheter manufactured for Stryker (SSS) FDA UDI
- Model / Reference
- R-S014R FDA UDI
- Description
- NES Reprocessed .014 IVUS Catheter manufactured for Stryker (SSS) FDA UDI
Identifiers
- Catalog Number
- R-S014R FDA UDI
- Primary DI / UDI-DI
- 00850044399208 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 .014 Stryker Catheter by Northeast Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8816fa47-b63e-4adc-87c8-2aaa00f16f26 36 fields · synced May 30, 2026