Identity
- Trade Name
- NES Reprocessed .035 Stryker Catheter FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- NES Reprocessed .035 IVUS reprocessed for Stryker (SSS) FDA UDI
- Model / Reference
- R-S88901 FDA UDI
- Description
- NES Reprocessed .035 IVUS reprocessed for Stryker (SSS) FDA UDI
Identifiers
- Catalog Number
- R-S88901 FDA UDI
- Primary DI / UDI-DI
- 00850044399239 FDA UDI
- 510(k) Number
- K181126 FDA UDI
- FDA Product Code
- OWQ FDA UDIOBJ 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 — 90 Centimeter FDA UDILumen/Inner Diameter — 0.035 Inch FDA UDI
Category: Intravascular ultrasound imaging catheter, reprocessed
NES Reprocessed .035 Stryker Catheter by Northeast Scientific, Inc. — 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
K181126 also covers:
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 7532fb61-1645-43ae-8b0a-09db7f60a06f 37 fields · synced May 31, 2026