Bone Fixator 1-Pin, X-Press Size-M 52422B

GUDID 04056481002350

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481002350
NIH Device Record Key7a20eb43-b5bf-4e63-a747-468b8d73336b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Fixator 1-Pin, X-Press Size-M
Version Model Number52422B
Catalog Number52422B
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 Batchfalse
Serial Numbertrue
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
GS104056481002350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481002350]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-15

On-Brand Devices [Bone Fixator 1-Pin, X-Press Size-M]

0405648100236752422A
0405648100235052422B

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