Em Instrument Reference 18099-05A

GUDID 04056481004873

Brainlab AG

Robotic surgical navigation system

Primary Device ID	04056481004873
NIH Device Record Key	cd44592a-bfb3-4a84-981b-b51f816cbd65
Commercial Distribution Status	In Commercial Distribution
Brand Name	Em Instrument Reference
Version Model Number	18099-05A
Catalog Number	18099-05A
Company DUNS	314482980
Company Name	Brainlab AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481004873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092467

FDA Product Code

HAW	Neurological Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

[04056481004873]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-15

Devices Manufactured by Brainlab AG

04056481143916 - Spine Planning	2024-11-13
04056481144654 - Viewer 5.4	2024-11-13
04056481143527 - DICOM Proxy	2024-11-01
04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.)	2024-07-26
04056481144920 - CRANIAL 4PI STEREOTACTIC MASK (1 PC.)	2024-07-26
04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.)	2024-07-26
04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.)	2024-07-26
04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.)	2024-07-26

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