Identity
- Trade Name
- TESSYS® / iLESSYS® Disposable Access KIT5 EUDAMEDTESSYS® FDA UDI
- Generic Name
- Lumbar decompression procedure kit FDA UDI
- Device Name
- TESSYS® / iLESSYS® Disposable Access KIT5 EUDAMEDTESSYS® Disposable Access KIT5, with4 Reamers fine FDA UDI
- Model / Reference
- TDAK0050 EUDAMEDFDA UDI
- Description
- TESSYS® Disposable Access KIT5, with4 Reamers fine FDA UDI
Identifiers
- Catalog Number
- TDAK0050 FDA UDI
- Primary DI / UDI-DI
- 04250337101093 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337101093 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- A01030101 SPINAL ANAESTHESIA NEEDLES AND KITS EUDAMED
- GMDN Term
- Lumbar decompression procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lumbar decompression procedure kit
Tessys® by Joimax, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 fc9dadbe-dd1c-4e06-a4cf-24c52fd7359c 35 fields · synced Jul 10, 2026
- EUDAMED 7d7c62a2-f328-4412-815f-790988904a10 61 fields · synced Jul 10, 2026