Identity
- Trade Name
- Fiber Optic Light Guide FDA UDI
- Generic Name
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
- Device Name
- Siepser shielded fiber optic light probe for identifying debris and fibers in the corneal interface or epithelium. , 20 ga, with Universal connector. Sterile, single-use. FDA UDI
- Model / Reference
- Siepser Shielded FDA UDI
- Description
- Siepser shielded fiber optic light probe for identifying debris and fibers in the corneal interface or epithelium. , 20 ga, with Universal connector. Sterile, single-use. FDA UDI
Identifiers
- Catalog Number
- TR9879-11 FDA UDI
- Primary DI / UDI-DI
- 00853480006105 FDA UDI
- 510(k) Number
- K875195 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Ophthalmic fibreoptic light instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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: Ophthalmic fibreoptic light instrument, single-use
Fiber Optic Light Guide by Escalon Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic fibreoptic light instrument, single-use.
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Cleared under the same submission
K875195 also covers:
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
- Fiber Optic Light Guide — ESCALON MEDICAL CORP
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
- Escalon Medical Corp
Sources (1)
- FDA UDI d38bdbb6-253b-4038-930f-1ee16259bcfd 37 fields · synced Jun 6, 2026