CONDUIT LLIF Straight Trial Inserter
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- CONDUIT LLIF Straight Trial Inserter EUDAMEDFDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Inserter EUDAMEDIntended to be used for the insertion of spinal trials into the spinal space during total artificial disc replacement surgery. FDA UDI
- Model / Reference
- LET20250T EUDAMEDFDA UDI
- Description
- Intended to be used for the insertion of spinal trials into the spinal space during total artificial disc replacement surgery. FDA UDI
Identifiers
- Catalog Number
- LET20250T FDA UDI
- Primary DI / UDI-DI
- 09421028117975 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN001628 EUDAMED
- Direct Marketing DI
- 09421028117975 EUDAMED
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic implant impactor, reusable
CONDUIT LLIF Straight Trial Inserter by Enztec Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102811GMN001628 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e04314f9-b102-47f5-8f93-f89d6f19b005 61 fields · synced Jun 18, 2026
- FDA UDI 22fa0802-d31c-4675-99db-cd59da7ea8af 34 fields · synced May 30, 2026