CRANIAL 4PI CT TABLE OVERLAY

GUDID 04056481141363

Brainlab AG

Indexed-immobilization patient positioning system
Primary Device ID04056481141363
NIH Device Record Key577d8616-7549-4deb-85ba-554a0e4bcc08
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANIAL 4PI CT TABLE OVERLAY
Version Model Number43430
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481141363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

Devices Manufactured by Brainlab AG

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
04056481144968 - CRANIAL 4PI OPEN FACE MASK (1 PC.)2024-07-26
04056481144975 - CRANIAL 4PI EXTENDED MASK (5 PCS.)2024-07-26
04056481144982 - CRANIAL 4PI EXTENDED MASK (1 PC.)2024-07-26

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