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LM-TwistOut S4
EUDAMEDFDA UDIClass I (EU MDR)
Ref 814240Model Hand instrument for tooth extraction
Identity
- Trade Name
- LM-TwistOut S4 EUDAMEDLMDental FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- LM-TwistOut S4, Extraction FDA UDI
- Model / Reference
- Hand instrument for tooth extraction EUDAMED814240 EUDAMEDFDA UDI
- Description
- LM-TwistOut S4, Extraction FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311221007 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438311221007 EUDAMED
- FDA Product Code
- EMJ FDA UDI
- EMDN Code
- L150301 DENTAL EXTRACTION TOOTH FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Dental elevator, tooth/root FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland 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
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
LM-TwistOut S4 by LM-Instruments Oy — 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-06438311221007 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED 6452d3a7-9156-4f5c-841c-d2757272dda4 61 fields · synced Jul 10, 2026
- FDA UDI dbb61b33-c316-45b5-ad14-35146e7d1959 33 fields · synced May 30, 2026