Identity
- Trade Name
- CONDUIT ATP Inserter Hex Driver EUDAMEDFDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Spinal Instruments EUDAMEDIntended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery. FDA UDI
- Model / Reference
- LET30401T EUDAMEDFDA UDI
- Description
- Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery. FDA UDI
Identifiers
- Catalog Number
- LET30401T FDA UDI
- Primary DI / UDI-DI
- 09421028118354 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00382J EUDAMED
- Direct Marketing DI
- 09421028118354 EUDAMED
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CONDUIT ATP Inserter Hex Driver by Enztec Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102811GMN00382J | 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 02858298-f7a2-43fb-9953-7ef6302ba066 61 fields · synced Jul 8, 2026
- FDA UDI 4d276280-f983-4ac8-b375-2fcf7d6b9db7 34 fields · synced May 30, 2026