Drill Bit 2.6 mm Depth Control (200 mm)

GUDID 04056481143183

Brainlab AG

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Primary Device ID04056481143183
NIH Device Record Keye2242b94-45d8-4cb2-ab05-cc32ae89be0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Bit 2.6 mm Depth Control (200 mm)
Version Model Number41839-68A
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
GS104056481143183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

Moist Heat or Steam Sterilization


[04056481143183]

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

On-Brand Devices [Drill Bit 2.6 mm Depth Control (200 mm)]

0405648114147941839-68
0405648114318341839-68A

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