Identity
- Trade Name
- Epimed FDA UDI
- Generic Name
- Peripheral nerve-block blunt needle access cannula FDA UDI
- Device Name
- 20g TW x 6.0" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
- Model / Reference
- 117-2060 FDA UDI
- Description
- 20g TW x 6.0" Coudé® Blunt Nerve Block Needle w/ Introducer FDA UDI
Identifiers
- Catalog Number
- 117-2060 FDA UDI
- Primary DI / UDI-DI
- 00818788020574 FDA UDI
- 510(k) Number
- K041843 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Peripheral nerve-block blunt needle access cannula 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
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDILength — 6 Inch FDA UDI
Category: Peripheral nerve-block blunt needle access cannula
Epimed by Epimed International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K041843 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epimed International, Inc
Sources (1)
- FDA UDI 00e25cdb-1d34-4c2c-a9fd-26aec8aa40f4 38 fields · synced Jun 8, 2026