Drill Bit 2.6 mm AO Shank

GUDID 04056481143176

Brainlab AG

Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system Robotic surgical navigation system
Primary Device ID04056481143176
NIH Device Record Keyf51c2e33-d612-46f2-85cc-c695bb8024d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Bit 2.6 mm AO Shank
Version Model Number41839-69A
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481143176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


[04056481143176]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-06
Device Publish Date2022-04-28

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04056481145392 - DRAPELINK REF ADAPTER AUTO-REG IMRI2023-10-24
04056481145101 - Automatic Registration2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA
04056481143138 - Drill Bit Cranial 2.4/4.02023-09-26
04056481143145 - Drill Bit Cranial 2.1/4.02023-09-26

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