Bl Impactor Universal Thread 3/8-16Unc 52855-34

GUDID 04056481002077

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481002077
NIH Device Record Keybc09052d-44e6-4c85-b602-442fb07b88fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameBl Impactor Universal Thread 3/8-16Unc
Version Model Number52855-34
Catalog Number52855-34
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exempttrue
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

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481002077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481002077]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

Devices Manufactured by Brainlab AG

04056481143916 - Spine Planning2024-11-13
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01
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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