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Cutter ejector
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref RPE280380
by Joimax, Inc.
Identity
- Trade Name
- Reamer Push-Ejector, green EUDAMEDCutter ejector FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- Reamer Push-Ejector, green EUDAMEDFDA UDI
- Model / Reference
- RPE280380 EUDAMEDFDA UDI
- Description
- Reamer Push-Ejector, green FDA UDI
Identifiers
- Catalog Number
- RPE280380 FDA UDI
- Primary DI / UDI-DI
- 04250337100911 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371REAMPEC9 EUDAMED
- Direct Marketing DI
- 04250337100911 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal endoscopic-access system
Cutter ejector by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal endoscopic-access system.
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- Trephine — ELLIQUENCE LLC · Class I
- Kerrison — ELLIQUENCE LLC · Class I
- Medfix — Medfix International, LLC · Class I
- Working Tube — ELLIQUENCE LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 37ca95cb-a50b-487c-9e96-165a31858dac 36 fields · synced Jul 8, 2026
- EUDAMED 633f98c6-4855-4762-a2a9-c0a320c41f17 61 fields · synced Jun 18, 2026