INTRABEAM® Surface Applicator Set 4.0 cm

GUDID 04049539101471

Carl Zeiss Meditec AG

Intraoperative/postoperative therapeutic x-ray system surface applicator
Primary Device ID04049539101471
NIH Device Record Keyb6fd0e8d-2333-47f0-8531-dea9de79b503
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRABEAM® Surface Applicator Set 4.0 cm
Version Model Number304534-3001-533
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter4 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104049539101471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JADSystem, Therapeutic, X-Ray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04049539101471]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-14

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04049539101358 - EyeMag Pro S2023-11-16
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Trademark Results [INTRABEAM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTRABEAM
INTRABEAM
75871021 2610253 Live/Registered
CARL ZEISS AG
1999-12-13

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