Identity
- Trade Name
- TESSYS® Cleaning Wire EUDAMEDTESSYS® FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- TESSYS® Cleaning Wire EUDAMEDFDA UDI
- Model / Reference
- TCW40010 EUDAMEDFDA UDI
- Description
- TESSYS® Cleaning Wire FDA UDI
Identifiers
- Catalog Number
- TCW40010 FDA UDI
- Primary DI / UDI-DI
- 04250337101048 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371DILAWIRCX EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
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
Tessys® 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
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- OptiLIF Endo, Direct Visualization System — SPINEOLOGY INC. · Class I
- MaxView™ System - Posterior Set — VISEON, INC. · Class II
- 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 277d1abb-be9c-4a34-b560-8c77e93b732d 36 fields · synced Jul 15, 2026
- EUDAMED a55ead7f-449a-42e5-9dc6-9e2356734380 61 fields · synced Jul 15, 2026