Identity
- Trade Name
- Leonhard Lang/Fannin Anti-Fog Kit; Sterile FDA UDI
- Generic Name
- Endoscope antifog solution FDA UDI
- Device Name
- Intended to be used as an anti-fog agent for endoscopic camera lenses FDA UDI
- Model / Reference
- FC0013 FDA UDI
- Description
- Intended to be used as an anti-fog agent for endoscopic camera lenses FDA UDI
Identifiers
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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope antifog solution
Leonhard Lang/Fannin Anti-Fog Kit +1 more model by Aspen Surgical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — 2 models
Similar devices
Also classified as Endoscope antifog solution.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Flo-X — Minimally Invasive Devices, LLC · Class II
- ClearIt Anti-Fog Kit — PRESERVATION SOLUTIONS, INC. · Class II
- Devon — Cardinalhealth · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Clearify — Covidien LP · Class II
- Anti-Fog w/ Pad — XODUS MEDICAL, INC. · Class II
- Merocel® ELVIS® — MEDTRONIC XOMED, INC. · Class II
Cleared under the same submission
K932449 also covers:
- ArcRoyal Anti-Fog, Regular Solution, Sterile — Aspen Surgical Products, Inc.
- Aspen® Anti-fog Solution — Aspen Surgical Products, Inc.
- Dr. Fog® Anti-fog Solution — Aspen Surgical Products, Inc.
- Dr. Fog® Solution With Sponge — Aspen Surgical Products, Inc.
- Dr. Fog® Solution With Sponge — Aspen Surgical Products, Inc.
- Dr. Fog® Treated Sponge — Aspen Surgical Products, Inc.
- Dr. Fog® Treated Sponge — Aspen Surgical Products, Inc.
- Dr. Fog® Treated Sponge — Aspen Surgical Products, Inc.
- Dr. Fog® Treated Sponge — Aspen Surgical Products, Inc.
- Medline Anti-Fog, Sterile — Aspen Surgical Products, Inc.
- Anti-Fog Kit — Batrik Medical Manufacturing Inc
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI f694435d-f6df-4f32-aa13-881195279328 35 fields · synced Jun 9, 2026