APEX Practice Managment Tool

GUDID 15420045507494

Hologic, Inc.

Bone absorptiometric x-ray system, dual-energy
Primary Device ID15420045507494
NIH Device Record Keya1bd7cae-5d1a-4413-a37e-baea5e0955e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX Practice Managment Tool
Version Model NumberAPEX Practice Managment Tool
Company DUNS153623137
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045507494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGIDensitometer, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-04

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