Identity
- Trade Name
- FLEX FDA UDI
- Generic Name
- Robotic surgical retractor FDA UDI
- Device Name
- RETRACTOR BODY FDA UDI
- Model / Reference
- 50220PKG FDA UDI
- Description
- RETRACTOR BODY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850190004469 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
No
FDA UDI
Serial Number
Yes
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
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Also classified as Robotic surgical retractor.
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- 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 9acee5b2-c116-415b-b3df-cf24772d35c3 33 fields · synced Jun 6, 2026