Brachy Column Extension D08040006

GUDID 00801741079184

Brachy Column Extension

C. R. Bard, Inc.

General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual
Primary Device ID00801741079184
NIH Device Record Key90ffd42b-bd25-4383-9707-8317b1658370
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrachy Column Extension
Version Model NumberD08040006
Catalog NumberD08040006
Company DUNS016898496
Company NameC. R. Bard, Inc.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)977-6733
Emailmedical.services@crbard.com
Phone+1(800)977-6733
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741079184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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