Identity
- Trade Name
- 93 NeuFlex Catheter FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The 93 NeuFlex Catheter (100148-002) has an inner diameter of 0.093" (6F compatible), a maximum outer diameter of 0.110", and a working length of 100 cm. FDA UDI
- Model / Reference
- 100148-002 FDA UDI
- Description
- The 93 NeuFlex Catheter (100148-002) has an inner diameter of 0.093" (6F compatible), a maximum outer diameter of 0.110", and a working length of 100 cm. FDA UDI
Identifiers
- Catalog Number
- 100148-002 FDA UDI
- Primary DI / UDI-DI
- 00860010306345 FDA UDI
- 510(k) Number
- K251044 FDA UDI
- FDA Product Code
- QJP FDA UDIDQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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: Vascular guide-catheter, single-use
93 NeuFlex Catheter by Piraeus Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K251044 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
- Piraeus Medical
Sources (1)
- FDA UDI e76675e2-60bd-4cf4-9186-f5090be9061b 35 fields · synced May 30, 2026