TRUNODE ASSY DEVICE 120-807605

GUDID 15420045512856

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 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 ID15420045512856
NIH Device Record Keyccddfaec-dc9a-480f-96c5-878e7981de4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUNODE ASSY DEVICE
Version Model Number120-807605
Catalog Number120-807605
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
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

Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045512856 [Primary]

FDA Product Code

IZDProbe, uptake, nuclear

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

[15420045512856]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

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