Em Disposable Stylet

FDA UDI

Class II (US FDA UDI)

by Brainlab SE

Identity

Trade Name: Em Disposable Stylet FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Model / Reference: 18097 FDA UDI

Identifiers

Catalog Number: 18097 FDA UDI
Primary DI / UDI-DI: 04056481006525 FDA UDI
510(k) Number: K092467 FDA UDI
K213989 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Robotic surgical navigation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Robotic surgical navigation system Intracranial catheter navigation transmitter stylet

Em Disposable Stylet by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K092467 also covers:

Headband Reference Star - Connector — Brainlab AG

K213989 also covers:

Curve Navigation 17700 — Brainlab SE

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Brainlab SE

Sources (1)

FDA UDI a6e923ec-9610-4f80-a5d9-435b09eafa30 35 fields · synced May 30, 2026