Identity
- Trade Name
- Portex FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Model / Reference
- 24-1014-64 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019517078794 FDA UDI
- 510(k) Number
- K172823 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Epidural needle, non-threaded FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 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
Yes
FDA UDI
Category: Epidural needle, non-threaded
Portex by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epidural needle, non-threaded.
- Entrada ™ — Boston Scientific Neuromodulation · Class III
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
- Halyard — AVID MEDICAL, INC. · Class II
- TUOHY — Pajunk GmbH Medizintechnologie · Class II
- TuohySono — Pajunk GmbH Medizintechnologie · Class II
- Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
- LCCS — Lccs Products Limited · Class II
Cleared under the same submission
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
- Icu Medical, Inc.
Sources (1)
- FDA UDI 5ad710e2-a77a-4bc2-87ab-65e7fb295ef0 33 fields · synced May 30, 2026