CRANIAL 4PI SPACER 20MM

GUDID 04056481145378

Brainlab AG

Indexed-immobilization patient positioning system
Primary Device ID04056481145378
NIH Device Record Key96158e1d-df8f-435d-b4ef-604b9a6e7410
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANIAL 4PI SPACER 20MM
Version Model Number43456
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481145378 [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 Date2025-07-04
Device Publish Date2025-06-26

Devices Manufactured by Brainlab AG

04056481145330 - CRANIAL 4PI HEADREST PLATFORM2025-07-04
04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD2025-07-04
04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.)2025-07-04
04056481145361 - CRANIAL 4PI WEDGE 10 DEG.2025-07-04
04056481145378 - CRANIAL 4PI SPACER 20MM2025-07-04
04056481145378 - CRANIAL 4PI SPACER 20MM2025-07-04
04056481145453 - CRANIAL 4PI INDEXING PLATE2025-07-04
04056481145460 - CRANIAL 4PI HEAD SUPPORT WIDE2025-07-04
04056481145477 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (1 PC.)2025-07-04

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