Identity
- Trade Name
- Epimed FDA UDI
- Generic Name
- Epidural/intrathecal anaesthesia set, non-medicated FDA UDI
- Device Name
- Wiley-Spinal™ Flexible Needle FDA UDI
- Model / Reference
- 199-2340 FDA UDI
- Description
- Wiley-Spinal™ Flexible Needle FDA UDI
Identifiers
- Catalog Number
- 199-2340 FDA UDI
- Primary DI / UDI-DI
- 00818788021694 FDA UDI
- 510(k) Number
- K043467 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Epidural/intrathecal anaesthesia set, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Epimed by Epimed International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Epimed International, Inc
Sources (1)
- FDA UDI 84d1ed49-071e-4e1b-b800-3959bd3c77a1 39 fields · synced Jun 6, 2026