Epimed 100-1417
Ref 100-1417Model Epidural Introducer Needle
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
None ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | Number081878802EINL2 00818788020024 | Date29 Jul 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number081878802EINL2 00818788020024 | Date29 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00818788020024 | Date24 Oct 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Terminated Z-0086-2017
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
EU market availability
Made available in 31 countries, as listed in EUDAMED:
- Austria since 4 Aug 2026
- Belgium since 4 Aug 2026
- Bulgaria since 4 Aug 2026
- Croatia since 4 Aug 2026
- Cyprus since 4 Aug 2026
- Czechia since 4 Aug 2026
- Denmark since 4 Aug 2026
- Estonia since 4 Aug 2026
- Finland since 4 Aug 2026
- France since 4 Aug 2026
- Germany since 4 Aug 2026
- Hungary since 4 Aug 2026
- Iceland since 4 Aug 2026
- Ireland since 4 Aug 2026
- Italy since 4 Aug 2026
- Latvia since 4 Aug 2026
- Liechtenstein since 4 Aug 2026
- Lithuania since 4 Aug 2026
- Luxembourg since 4 Aug 2026
- Malta since 4 Aug 2026
- Netherlands since 4 Aug 2026
- Northern Ireland since 4 Aug 2026
- Norway since 4 Aug 2026
- Poland since 4 Aug 2026
- Portugal since 4 Aug 2026
- Romania since 4 Aug 2026
- Slovakia since 4 Aug 2026
- Slovenia since 4 Aug 2026
- Spain since 4 Aug 2026
- Sweden since 4 Aug 2026
- Türkiye since 4 Aug 2026
Specification
- Trade Name
- Epimed International,Inc. EUDAMEDEpimed GUDID
- Generic Name
- Epidural needle, non-threaded
- Model / Ref / Catalog
- 100-1417, Epidural Introducer Needle
- Description
- R.K.™ 17g XTW x 3.5"
- Primary DI / UDI-DI
- 00818788020024
- Basic UDI-DI
- 081878802EINL2, B-00818788020024
- 510(k) Number
- FDA Product Code
- BSP
- EMDN Code
- A01030102 Epidural anaesthesia needles and kits
- GMDN Term
- Epidural needle, non-threaded
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.5150
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
- MRI Safety
- MR Unsafe
- Size
- Needle Gauge — 17 GaugeLength — 3.5 Inch
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Epimed International, Inc
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No