Identity
- Trade Name
- Flo-X FDA UDI
- Generic Name
- Endoscope antifog solution FDA UDI
- Device Name
- The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally invasive surgery while maintaining visualization of the surgical site. FDA UDI
- Model / Reference
- FX10 FDA UDI
- Description
- The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally invasive surgery while maintaining visualization of the surgical site. FDA UDI
Identifiers
- Catalog Number
- FX10 FDA UDI
- Primary DI / UDI-DI
- 00815128020652 FDA UDI
- FDA Product Code
- OCT FDA UDI
- GMDN Term
- Endoscope antifog solution 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
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Endoscope antifog solution
Flo-X by Minimally Invasive Devices, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope antifog solution.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- ClearIt Anti-Fog Kit — PRESERVATION SOLUTIONS, INC. · Class II
- Devon — Cardinalhealth · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- ArcRoyal Anti-Fog, Regular Solution, Sterile — Aspen Surgical Products, Inc. · Class II
- Clearify — Covidien LP · Class II
- Anti-Fog w/ Pad — XODUS MEDICAL, INC. · Class II
- Dr. Fog® Treated Sponge — Aspen Surgical Products, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Minimally Invasive Devices, LLC
Sources (1)
- FDA UDI 7b9c98bf-2670-4608-9072-4b84f67be2bd 37 fields · synced May 30, 2026