Identity
- Trade Name
- Dexter Needle Holder FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Dexter L6 Needle Holder FDA UDI
- Model / Reference
- Dexter L6 FDA UDI
- Description
- Dexter L6 Needle Holder FDA UDI
Identifiers
- Catalog Number
- 705 FDA UDI
- Primary DI / UDI-DI
- 07640184840455 FDA UDI
- 510(k) Number
- DEN230084 FDA UDI
- FDA Product Code
- SDD FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4965 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Robotic surgical arm system
Dexter Needle Holder by Distalmotion SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
- daVinci Xi — Intuitive Surgical, Inc. · Class II
- SHURUI Large Tissue Forceps — Beijing Surgerii Robotics Company Limited · Class IIb
- FLEX — Medrobotics Corporation · Class II
- Flex — Medrobotics Corporation · Class II
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
DEN230084 also covers:
- Dexter Bipolar Johann Grasper — Distalmotion SA
- Dexter Bipolar Maryland Dissector — Distalmotion SA
- Dexter L6 Accessory tray — Distalmotion SA
- Dexter L6 Endoscope Cart — Distalmotion SA
- Dexter L6 Handle Grip — Distalmotion SA
- Dexter L6 Robot — Distalmotion SA
- Dexter Monopolar Hook — Distalmotion SA
- Dexter Monopolar Scissors — Distalmotion SA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Distalmotion SA
Sources (1)
- FDA UDI 23ac87f8-d3fa-4516-bb50-8a2bbc6122b3 36 fields · synced May 30, 2026