Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, reprocessed FDA UDI
- Device Name
- BW ACUNAV SIEMENS CATH 4WAY 160DEG 10FR FDA UDI
- Model / Reference
- 08255790RH FDA UDI
- Description
- BW ACUNAV SIEMENS CATH 4WAY 160DEG 10FR FDA UDI
Identifiers
- Catalog Number
- 08255790RH FDA UDI
- Primary DI / UDI-DI
- 10197344149537 FDA UDI
- 510(k) Number
- K243101 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
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Also classified as Intravascular ultrasound imaging catheter, reprocessed.
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Cleared under the same submission
K243101 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 5a9c9920-a6cb-42c2-a1fc-ea4e91ab3c22 36 fields · synced May 30, 2026