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Spectra Epidural Needle
EUDAMEDFDA UDIClass III (EU MDR)
Ref S88518-3.501SModel 0140-079-00
Identity
- Trade Name
- Spectra Epidural Needle EUDAMEDTuohy Epidural Needle FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Device Name
- Spectra Epidural Needles EUDAMEDPlastic Standard Hub Tuohy Epidural Needle, 18G x 3.50", Metal Stylet, Marks, Bevel Indicator FDA UDI
- Model / Reference
- 0140-079-00 EUDAMEDS88518-3.501S EUDAMEDFDA UDI
- Description
- Plastic Standard Hub Tuohy Epidural Needle, 18G x 3.50", Metal Stylet, Marks, Bevel Indicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- ++M661Epidural3QX EUDAMEDM661S885183501 FDA UDI
- Basic UDI-DI
- B-++M661Epidural3QX EUDAMED
- 510(k) Number
- K854816 FDA UDI
- FDA Product Code
- BSP FDA UDI
- EMDN Code
- A01030102 EPIDURAL ANAESTHESIA NEEDLES AND KITS EUDAMED
- GMDN Term
- Epidural needle, non-threaded FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5150 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Spectra Epidural Needle by Spectra Medical Devices, LLC — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-++M661Epidural3QX | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Spectra Medical Devices, LLC
- EUDAMED SRN
- US-MF-000008491
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 25aa7126-60c4-4944-bdc7-e1ab9904b6c1 61 fields · synced Oct 6, 2026
- FDA UDI 468b9b7d-3418-4974-9852-0f4886128066 34 fields · synced May 29, 2026