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Reference Adapter Drapelink for Auto-Registration iMRI

FDA UDI

Class II (US FDA UDI)

by Brainlab SE

Identity

Trade Name
Reference Adapter Drapelink for Auto-Registration iMRI FDA UDI
Generic Name
Robotic surgical navigation system FDA UDI
Model / Reference
19208-02 FDA UDI

Identifiers

Primary DI / UDI-DI
04056481141417 FDA UDI
510(k) Number
K092467 FDA UDI
K223288 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Robotic surgical navigation system

Reference Adapter Drapelink for Auto-Registration iMRI by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical navigation system.

Cleared under the same submission

K092467 also covers:

K223288 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brainlab SE

Sources (1)

  • FDA UDI ea9683b0-9e3d-41ae-b3fd-fbc3a9f9a1b1 33 fields · synced May 30, 2026