Brainlab AG

Address:Olof-Palme-Strasse 9,Munich Bavaria,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Stereotaxic Instrument (OLO) (4) Neurological Stereotaxic Instrument (HAW) (3) System, Digital Image Communications, Radiological (LMD) (2) Drape, Surgical, Exempt (PUI) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

Drill Bit 2.4 mm AO Shank - 04056481143237 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Drill Bit 2.4 mm AO Shank Depth Control - 04056481143244 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Loop-X Disposable Sterile Drape Set - 04056481143299 Catalog Number :

Device Description : The Loop-X Disposable Sterile Drape Set is an accessory for the Loop-X imaging d The Loop-X Disposable Sterile Drape Set is an accessory for the Loop-X imaging device. The drape set creates a sterile barrier between the OR field and the imaging device, allowing intraoperative 2D imaging of patients in a sterile environment.

Device Class : 2

Duns Number: 314482980

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

Buzz 2.0 - 04056481143305 Catalog Number :

Device Class : 1

Duns Number: 314482980

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Kick 2 Navigation Station - 04056481143503 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO, HAW

Prescription Use : Yes

Device Count : 1

DICOM Proxy - 04056481143527 Catalog Number :

Device Class : 1

Duns Number: 314482980

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Elements Viewer - 04056481143619 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

DRILL BIT CRANIAL 3.4/3.8 - 04056481143701 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Cirq Instrument Holder Module - 04056481143718 Catalog Number :

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Kick 2 Navigation Station EM - 04056481143725 Catalog Number :

Device Description : The platform hosts one or more Brainlab Software Applications. It incorporates a The platform hosts one or more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery (IGS) purposes.

Device Class : 2

Duns Number: 314482980

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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