Kingmark Assembly 54243-12

GUDID 04056481001766

Brainlab AG

Radiographic image marker, automatic
Primary Device ID04056481001766
NIH Device Record Key4f933fe5-4760-4444-a3bf-751d947b6349
Commercial Distribution StatusIn Commercial Distribution
Brand NameKingmark Assembly
Version Model Number54243-12
Catalog Number54243-12
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481001766 [Primary]

FDA Product Code

JACSystem, X-Ray, Film Marking, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

Devices Manufactured by Brainlab AG

04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm2025-03-04
04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm2025-03-04
04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm2025-03-04
04056481145910 - Drill Bit Cranial 4.5 mm /4.9 mm2025-03-04
04056481145927 - Drill Depth Stop Cranial 4.9 mm2025-03-04
04056481146047 - Cirq Robotic Tracking Array 10.02025-03-04
04056481146337 - Alignment Software Cranial with LITT2025-03-04
04056481146719 - Sterilization Tray Cirq® Robotic Alignment LITT2025-03-04

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