Identity
- Trade Name
- Irrigating Contact Lens FDA UDI
- Generic Name
- Vitrectomy contact lens, single-use FDA UDI
- Device Name
- For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single use requiring no clean up. FDA UDI
- Model / Reference
- Minus FDA UDI
- Description
- For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single use requiring no clean up. FDA UDI
Identifiers
- Catalog Number
- TR9841-11 FDA UDI
- Primary DI / UDI-DI
- 00853480006143 FDA UDI
- 510(k) Number
- K924999 FDA UDI
- FDA Product Code
- KYG FDA UDI
- GMDN Term
- Vitrectomy contact lens, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4360 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: Vitrectomy contact lens, single-use
Irrigating Contact Lens by Escalon Medical Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitrectomy contact lens, single-use.
- MAGNIFIER LENS — Katena Products, Inc. · Class II
- PHAKOS — Phakos · Class II
- HD LenZ Pack for ZEISS RESIGHT® — OCULUS SURGICAL INC · Class II
- PHAKOS — Phakos · Class II
- Disposable 30 Deg. Vitrectomy — OCULAR INSTRUMENTS, INC. · Class II
- Disposable Direct Image 1.5x Mag (VMD) — VOLK OPTICAL INC. · Class II
- PHAKOS — Phakos · Class II
- PHAKOS — Phakos · Class II
Cleared under the same submission
K924999 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Escalon Medical Corp
Sources (1)
- FDA UDI 9401d81a-8eb4-45bc-8d74-53a726eeed68 37 fields · synced May 30, 2026