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Lcs Completion
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 2178-61-095Model S-ROM NOILES Screwdriver
Identity
- Trade Name
- LCS COMPLETION EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screwdriver EUDAMEDLCS Completion COMP REVISION HEX SCREWDRIVER 2.5mm FDA UDI
- Model / Reference
- 2178-61-095 EUDAMEDFDA UDIS-ROM NOILES Screwdriver EUDAMED
- Description
- LCS Completion COMP REVISION HEX SCREWDRIVER 2.5mm FDA UDI
Identifiers
- Catalog Number
- 217861095 FDA UDI
- Primary DI / UDI-DI
- 10603295096009 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0004082 EUDAMED
- Direct Marketing DI
- 10603295096009 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland 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
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
Yes
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
Category: Surgical screwdriver, reusable
Lcs Completion by Depuy Orthopaedics, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
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- CosmoLock Pedicle Screw System — Kalitec Direct 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
- Depuy Orthopaedics, Inc.
Sources (2)
- FDA UDI 64796c13-6b61-47a8-8ed6-47d3e6ed9f0f 35 fields · synced Jul 11, 2026
- EUDAMED 1d06fe41-ac84-4283-a90d-8267213f3f34 61 fields · synced Jul 11, 2026