INTRABEAM SMART Stand

GUDID 04049539066503

The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system
Primary Device ID04049539066503
NIH Device Record Key1512b33e-60e9-4a45-a0fd-9ba751e78646
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRABEAM SMART Stand
Version Model Number6650
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS104049539066503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-09
Device Publish Date2025-04-01

Devices Manufactured by Carl Zeiss Meditec AG

04049539064080 - INTRABEAM2025-04-09 The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be pla
04049539066503 - INTRABEAM SMART Stand2025-04-09 The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
04049539066503 - INTRABEAM SMART Stand2025-04-09 The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-
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