Identity
- Trade Name
- FLEX FDA UDI
- Generic Name
- Robotic surgical retractor FDA UDI
- Device Name
- STRAIGHT LARYNGEAL BLADE, 85-115mm X 36mm Proximal X 23mm Distal FDA UDI
- Model / Reference
- 50205PKG FDA UDI
- Description
- STRAIGHT LARYNGEAL BLADE, 85-115mm X 36mm Proximal X 23mm Distal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850190004391 FDA UDI
- FDA Product Code
- KAL FDA UDI
- GMDN Term
- Robotic surgical retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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: Robotic surgical retractor
Flex by Medrobotics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical retractor.
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- EndoWrist SP — Intuitive Surgical, Inc. · Class II
- EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
- EndoWrist SP — Intuitive Surgical, Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medrobotics Corporation
Sources (1)
- FDA UDI b5fd3c23-d9c4-4e81-85cc-3a7ef29f9306 33 fields · synced May 30, 2026