BMT Armrest Armature & Table Clamp

GUDID 00860003072721

CONCURE ONCOLOGY, INC.

Manual brachytherapy system
Primary Device ID00860003072721
NIH Device Record Keya754adbe-9e75-4be0-aa50-f1e12f5508f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBMT Armrest Armature & Table Clamp
Version Model NumberAC-B3040
Company DUNS056124661
Company NameCONCURE ONCOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003072721 [Primary]

FDA Product Code

IWJSystem, Applicator, Radionuclide, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-13
Device Publish Date2020-08-05

Devices Manufactured by CONCURE ONCOLOGY, INC.

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00860003072714 - BMT Template Grid Armature & Table Clamp2020-08-13
00860003072721 - BMT Armrest Armature & Table Clamp2020-08-13
00860003072721 - BMT Armrest Armature & Table Clamp2020-08-13
00860003072738 - BMT Template Grid, Vertical Lock, Large2020-08-13
00860003072745 - BMT Cleaning Brush Set, Vertical Lock2020-08-13
00860003072752 - BMT Fiducial Needle, Sharp2020-08-13
00860003072769 - BMT Fiducial Needle, Round2020-08-13

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