INTRABEAM SMART Spherical Applicator (40mm)

GUDID 04049539105561

Carl Zeiss Meditec AG

Nucleic acid microarray probe chip IVD
Primary Device ID04049539105561
NIH Device Record Key20a620e5-2dfa-4200-a625-ffc6d5c8a728
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRABEAM SMART Spherical Applicator (40mm)
Version Model Number309120-9040-000
Company DUNS342228620
Company NameCarl Zeiss Meditec 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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049539105561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-22
Device Publish Date2025-05-14

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