Identity
- Trade Name
- Flex FDA UDI
- Generic Name
- Laser beam delivery unit holder FDA UDI
- Device Name
- Micro Flex Laser Holder 1100 FDA UDI
- Model / Reference
- 50644 FDA UDI
- Description
- Micro Flex Laser Holder 1100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850190004681 FDA UDI
- 510(k) Number
- K140662 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Laser beam delivery unit holder 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
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: Laser beam delivery unit holder
Flex by Medrobotics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laser beam delivery unit holder.
- INTRALASE TECHNOLOGY PI — Johnson & Johnson Surgical Vision, Inc. · Class II
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- FS DISPOSABLE INTERFACE — Johnson & Johnson Surgical Vision, Inc. · Class I
- FS DISPOSABLE INTERFACE — Johnson & Johnson Surgical Vision, Inc. · Class I
- INTRALASE TECHNOLOGY PI — Johnson & Johnson Surgical Vision, Inc. · Class II
- Resectoscopy bridge — SOPRO-COMEG GmbH · Class II
- Resectoscopy bridge — SOPRO-COMEG GmbH · Class II
- FLEX — Medrobotics Corporation · Class II
Cleared under the same submission
K140662 also covers:
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- FLEX — Medrobotics Corporation
- Flex — Medrobotics Corporation
- Flex — Medrobotics Corporation
- Flex — Medrobotics Corporation
- Flex — Medrobotics Corporation
- Flex — Medrobotics Corporation
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
- Medrobotics Corporation
Sources (1)
- FDA UDI 662b8071-5a30-49bc-9768-f5e31aae0811 34 fields · synced Jun 1, 2026