Identity
- Trade Name
- Inserter Coupling Screw 7mm & 8mm EUDAMEDFDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- Inserter Coupling Screw 7mm & 8mm EUDAMEDInstrument used to couple the cap of the WasherCap™ Fixation System to the inserter, threading it into the inserter until the “device-inserter” assembly is fully engaged. FDA UDI
- Model / Reference
- ATMWCIN61 EUDAMED21 FDA UDI
- Description
- Instrument used to couple the cap of the WasherCap™ Fixation System to the inserter, threading it into the inserter until the “device-inserter” assembly is fully engaged. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019739553 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08437019739553 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Inserter Coupling Screw 7mm & 8mm by Abanza Tecnomed, S.l. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08437019739553 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Abanza Tecnomed, S.l.
- EUDAMED SRN
- ES-MF-000007530
Sources (2)
- EUDAMED 914ed6ad-1af3-4bf1-afc6-72523b5f8e5b 61 fields · synced Jul 10, 2026
- FDA UDI 80bf9fef-8405-498f-8025-26073f28f06d 34 fields · synced May 30, 2026