Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- BW SOUNDSTAR ECO CATH 8FR 90CM GE FDA UDI
- Model / Reference
- 10439236RH FDA UDI
- Description
- BW SOUNDSTAR ECO CATH 8FR 90CM GE FDA UDI
Identifiers
- Catalog Number
- 10439236RH FDA UDI
- Primary DI / UDI-DI
- 10197344157303 FDA UDI
- 510(k) Number
- K250545 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
Category: Intravascular ultrasound imaging catheter, reprocessed
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular ultrasound imaging catheter, reprocessed.
- NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter — NORTHEAST SCIENTIFIC, 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
- NES Reprocessed Eagle Eye Platinum Short Tip Stryker — NORTHEAST SCIENTIFIC, INC. · Class II
- NES Reprocessed .035 Stryker Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- NES Reprocessed Eagle Eye Platinum Short Tip Stryker — NORTHEAST SCIENTIFIC, INC. · Class II
- NES Reprocessed Visions PV .035 Digital IVUS Catheter — NORTHEAST SCIENTIFIC, INC. · Class II
- NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip — NORTHEAST SCIENTIFIC, INC. · Class II
Cleared under the same submission
K250545 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 679f3144-c379-4cf8-a581-6ddf4b5b0e79 36 fields · synced May 30, 2026