Identity
- Trade Name
- Dexter EUDAMEDDexter L6 Emergency Release Tool FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Emergency Release Tool EUDAMEDDexter L6 Emergency Release Tool FDA UDI
- Model / Reference
- Dexter L6 EUDAMEDFDA UDI487 EUDAMED
- Description
- Dexter L6 Emergency Release Tool FDA UDI
Identifiers
- Catalog Number
- 487 FDA UDI
- Primary DI / UDI-DI
- 07640184840196 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018484AC-RU-ERT001NZ EUDAMED
- Direct Marketing DI
- 07640184840196 EUDAMED
- 510(k) Number
- DEN230084 FDA UDI
- FDA Product Code
- SDD FDA UDI
- EMDN Code
- Z12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMED
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4965 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dexter by Distalmotion SA — 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 | 764018484AC-RU-ERT001NZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Distalmotion SA
- EUDAMED SRN
- CH-MF-000037226
- Authorised Representative
- Distalmotion Deutschland GmbH DE-AR-000046740
Sources (2)
- EUDAMED 951a074e-ecc2-4fba-b39d-acd621b26439 61 fields · synced Jul 17, 2026
- FDA UDI a73ba5c5-4792-436b-92fd-ea98f09bcd11 36 fields · synced May 30, 2026