Identity
- Trade Name
- Temena FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Device Name
- Epidural needle Rodiera 17/18G x 90 mm FDA UDI
- Model / Reference
- 00517-18 FDA UDI
- Description
- Epidural needle Rodiera 17/18G x 90 mm FDA UDI
Identifiers
- Catalog Number
- 00517-18 FDA UDI
- Primary DI / UDI-DI
- 03700339710096 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
No
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
- Length — 90 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
Category: Epidural needle, non-threaded
Temena by Te ME NA Sas — 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
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
- Te ME NA Sas
Sources (1)
- FDA UDI a98c382b-3a3f-4564-b735-ef752006d5a6 35 fields · synced Jun 8, 2026