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Sterilized Endophoto Probe(20G/Straight)
FDA UDIClass II (US FDA UDI)
by Nidek, Inc.
Identity
- Trade Name
- Sterilized Endophoto Probe(20G/Straight) FDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters. FDA UDI
- Model / Reference
- 11143-6100 FDA UDI
- Description
- It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101230 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
- Needle Gauge — 20 Gauge FDA UDI
Category: Ophthalmic laser system beam guide
Sterilized Endophoto Probe(20G/Straight) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic laser system beam guide.
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- OtoProbe™ Short Angled Box of 6 — Iridex Corporation · 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
- Nidek, Inc.
Sources (1)
- FDA UDI f7b2891b-f64d-416d-ae4d-13fb8fa051a6 35 fields · synced May 30, 2026