Bl 3.2mm Pindriver (ao Interface)

FDA UDI

Class II (US FDA UDI)

by Brainlab SE

Identity

Trade Name: BL 3.2MM PINDRIVER (AO INTERFACE) FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Model / Reference: 54932A FDA UDI

Identifiers

Catalog Number: 54932A FDA UDI
Primary DI / UDI-DI: 04056481094928 FDA UDI
510(k) Number: K102990 FDA UDI
K193307 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Bl 3.2mm Pindriver (ao Interface) by Brainlab SE — 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.

K193307 also covers:

HIP7 — Brainlab AG

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 2ddafc34-487f-45b4-88f4-de03e88afbb1 36 fields · synced May 30, 2026