Identity
- Trade Name
- Tuohy Epidural Needle FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Device Name
- 17G x 3 1/2"(89mm) Plastic hub With wings, calibrations FDA UDI
- Model / Reference
- 3-2150-17 FDA UDI
- Description
- 17G x 3 1/2"(89mm) Plastic hub With wings, calibrations FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04526737170787 FDA UDI
- 510(k) Number
- K961152 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 17 Gauge FDA UDILength — 89 Millimeter FDA UDI
Category: Epidural needle, non-threaded
Tuohy Epidural Needle by Hakko Co., Ltd. — 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
K961152 also covers:
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- EchoTuohy Epidural Needle — HAKKO CO., LTD.
- Tuohy Epidural Needle — HAKKO CO., LTD.
- Tuohy Epidural Needle — HAKKO CO., LTD.
- Tuohy Epidural Needle — HAKKO CO., LTD.
- Tuohy Epidural Needle — HAKKO CO., LTD.
- Tuohy Epidural Needle — HAKKO CO., LTD.
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
- Hakko Co., Ltd.
Sources (1)
- FDA UDI 9383bc19-8d95-4aa7-9fd7-bf580ea9aec5 36 fields · synced Jun 6, 2026