DEVICE: Em Disposable Stylet (04056481006525)

Device Identifier (DI) Information

Em Disposable Stylet
18097
In Commercial Distribution
18097
Brainlab SE
04056481006525
GS1

1
314482980 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38723 Robotic surgical navigation system
An assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.
Active false
63570 Intracranial catheter navigation transmitter stylet
A sterile, invasive, flexible wire with an electromagnetic (EM) coil transmitter at the distal end designed to be inserted into an intracranial catheter to help guide the surgical insertion of the catheter through the skull for placement in the brain. It is proximally connected to a line-powered EM neurosurgical navigation system which tracks and displays the position of the stylet for precise navigation during the procedure. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological Stereotaxic Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092467 000
K213989 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a6e923ec-9610-4f80-a5d9-435b09eafa30
September 17, 2025
6
February 08, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04056481004958 10 04056481006525 In Commercial Distribution
04056481004965 1 04056481006525 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49899915680
contact@brainlab.com
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