GONIO ready® 200 for f=200

FDA UDI

Class I (US FDA UDI)

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Identity

Trade Name: GONIO ready® 200 for f=200 FDA UDI
Generic Name: Microscope objective FDA UDI
Device Name: GONIO ready® 200 for f=200 FDA UDI
Model / Reference: 10008422 FDA UDI
Description: GONIO ready® 200 for f=200 FDA UDI

Identifiers

Primary DI / UDI-DI: 04049584034465 FDA UDI
FDA Product Code: HKS FDA UDI
GMDN Term: Microscope objective FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microscope objective

GONIO ready® 200 for f=200 by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — 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: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Sources (1)

FDA UDI 689564a1-726d-4899-861c-0867b9179656 34 fields · synced May 30, 2026