Epsilon USA

FDA UDI

Class I (US FDA UDI)

by Epsilon Eye Care Private Limited

Identity

Trade Name: Epsilon USA FDA UDI
Generic Name: Ophthalmic calliper FDA UDI
Device Name: Ogawa Bi-Manual Irrigator 23G Titanium FDA UDI
Model / Reference: EB-23i FDA UDI
Description: Ogawa Bi-Manual Irrigator 23G Titanium FDA UDI

Identifiers

Primary DI / UDI-DI: G346EB23I0 FDA UDI
FDA Product Code: HOE FDA UDI
GMDN Term: Ophthalmic calliper FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Ophthalmic calliper

The Ogawa Bi-Manual Irrigator 23G Titanium is a high-quality, hand-held ophthalmic measuring instrument designed to accurately measure the diameter, length, angles, and thicknesses of the eye. This comprehensive device features two hinged legs for precise measurements, along with advanced technology for reliable data collection. Its ergonomic design and user-friendly interface make it an ideal tool for ophthalmologists and optometrists.

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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

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Manufacturer

Manufacturer: Epsilon Eye Care Private Limited

Sources (1)

FDA UDI 77337e95-4f3c-4dfd-bc23-2d4389ef5999 34 fields · synced Jun 20, 2026