Identity
- Trade Name
- FLEX FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- TA Case Kit 2 FDA UDI
- Model / Reference
- 26471 FDA UDI
- Description
- TA Case Kit 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850190004841 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Robotic surgical arm system
Flex by Medrobotics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
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- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
- daVinci Si — Intuitive Surgical, Inc. · Class II
- Adapter, Passive Allis Grasper, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- NOVADAQ 10 mm Endoscope Adapter — Asensus Surgical Italia S.r.l. · Class I
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 |
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Manufacturer
- Manufacturer
- Medrobotics Corporation
Sources (1)
- FDA UDI 63ab4fcb-5f90-41d6-a321-4bb634d3d38c 33 fields · synced May 30, 2026