Pentero® 800 S

FDA UDI

Class I (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name: PENTERO® 800 S FDA UDI
Generic Name: General-purpose surgical microscope FDA UDI
Model / Reference: 6410 FDA UDI

Identifiers

Primary DI / UDI-DI: 04049539064103 FDA UDI
FDA Product Code: FSO FDA UDI
GMDN Term: General-purpose surgical microscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4700 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: General-purpose surgical microscope

Pentero® 800 S by Carl Zeiss Meditec AG — 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: Carl Zeiss Meditec AG

Sources (1)

FDA UDI 273c3cef-c0b6-4011-b150-c11e07e56ba5 32 fields · synced May 31, 2026