Brainlab Elements Contouring

FDA UDI

Class II (US FDA UDI)

by Brainlab SE

Identity

Trade Name: Brainlab Elements Contouring FDA UDI
Generic Name: Stereotactic system application software FDA UDI
Model / Reference: 4.5 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056481144623 FDA UDI
510(k) Number: K223106 FDA UDI
FDA Product Code: QIH FDA UDI
JAK FDA UDI
LLZ FDA UDI
GMDN Term: Stereotactic system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.1750 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Stereotactic system application software

Brainlab Elements Contouring by Brainlab SE — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Brainlab SE

Sources (1)

FDA UDI f3e439d3-c890-4f3b-9b7a-06f5413f77cf 33 fields · synced May 30, 2026