Identity
- Trade Name
- Epimed FDA UDI
- Generic Name
- Epidural/intrathecal anaesthesia set, non-medicated FDA UDI
- Device Name
- Wiley Spinal®+ 4" FDA UDI
- Model / Reference
- 188-2340 FDA UDI
- Description
- Wiley Spinal®+ 4" FDA UDI
Identifiers
- Catalog Number
- 188-2340 FDA UDI
- Primary DI / UDI-DI
- 00818788021458 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
Dimensions & Sizes
- Size
- Length — 4 Inch 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 f14c9b80-1b91-4ded-94c5-8e0cf2cbbd33 39 fields · synced Jun 4, 2026