Buzz 2.0

FDA UDI

Class I (US FDA UDI)

by Brainlab SE

Identity

Trade Name: Buzz 2.0 FDA UDI
Generic Name: Medical image management system FDA UDI
Model / Reference: 15800A FDA UDI

Identifiers

Primary DI / UDI-DI: 04056481143305 FDA UDI
FDA Product Code: LMD FDA UDI
GMDN Term: Medical image management system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.2020 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 Conditional FDA UDI

Category: Medical image management system

Buzz 2.0 by Brainlab SE — 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: Brainlab SE

Sources (1)

FDA UDI ba14dc2e-a5d4-493e-be21-50f5f7d06f0f 32 fields · synced May 30, 2026