CalTray

FDA UDI

Class I (US FDA UDI)

by Epsilon Eye Care Private Limited

Identity

Trade Name: CalTray FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Plastic Instrument Tray: Double Level 6 x 10 x 2.0" (Base, Lid, Finger Mat., & Insert Tray With Mat) FDA UDI
Model / Reference: P150 FDA UDI
Description: Plastic Instrument Tray: Double Level 6 x 10 x 2.0" (Base, Lid, Finger Mat., & Insert Tray With Mat) FDA UDI

Identifiers

Primary DI / UDI-DI: G346P1500 FDA UDI
FDA Product Code: FSM FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Instrument tray, reusable

CalTray by Epsilon Eye Care Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 88e4131e-a83d-4853-bd83-1ae395bd1d6f 34 fields · synced Jun 6, 2026