INTRABEAM SMART Spherical Applicator

GUDID 04049539105530

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use
Primary Device ID04049539105530
NIH Device Record Key21e1f51c-31ee-4e82-9eed-597008e6fad7
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRABEAM SMART Spherical Applicator
Version Model Number309120-9025-000
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
GS104049539105530 [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

On-Brand Devices [INTRABEAM SMART Spherical Applicator ]

04049539105530309120-9025-000
04049539105523309120-9020-000
04049539105516309120-9015-00

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