Identity
- Trade Name
- Scope Working Tube Distance Ring iLESSYS® Delta EUDAMEDiLESSYS® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- Working Tube Chisel EUDAMEDScope Working Tube Distance Ring iLESSYS® Delta FDA UDI
- Model / Reference
- SWTDR1009 EUDAMEDFDA UDI
- Description
- Scope Working Tube Distance Ring iLESSYS® Delta FDA UDI
Identifiers
- Catalog Number
- SWTDR1009 FDA UDI
- Primary DI / UDI-DI
- 04250337115267 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371WOTUTUBY9 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
iLESSYS® 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.
- Kerrison — ELLIQUENCE LLC · Class I
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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 54c9ed22-4360-45c7-8819-2e66991c28bf 36 fields · synced Jun 18, 2026
- EUDAMED f6c353b7-b3d4-4a85-919d-c3b0cced34c9 61 fields · synced Jun 18, 2026