Brainlab Pointer, Angled

FDA UDI

Class II (US FDA UDI)

by Brainlab AG

Identity

Trade Name: Brainlab Pointer, Angled FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Model / Reference: 41784B FDA UDI

Identifiers

Catalog Number: 41784B FDA UDI
Primary DI / UDI-DI: 04056481003555 FDA UDI
510(k) Number: K102990 FDA UDI
FDA Product Code: OLO 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: Not 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Brainlab Pointer, Angled by Brainlab AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102990 also covers:

Clearlens — Smith & Nephew, Inc.
Clearlens — Smith & Nephew, Inc.

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 AG

Sources (1)

FDA UDI ecfbe6fd-725e-4d8b-be10-fb973e75ac20 36 fields · synced Jun 6, 2026