TruNode 120-807606

GUDID 15420045514416

Hologic, Inc.

Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system Hand-held-detector nuclear medicine system
Primary Device ID15420045514416
NIH Device Record Keyfdb77b71-371d-4cc3-adcf-4b196fc4e994
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruNode
Version Model Number120-807606
Catalog Number120-807606
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045514416 [Primary]

FDA Product Code

IZDProbe, uptake, nuclear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01

On-Brand Devices [TruNode]

15420045514416120-807606
15420045514638120-807611

Trademark Results [TruNode]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUNODE
TRUNODE
86519309 4838402 Live/Registered
FAXITRON BIOPTICS, LLC
2015-01-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.