Horizon Wi

GUDID 15420045505865

Hologic, Inc.

Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy Bone absorptiometric x-ray system, dual-energy
Primary Device ID15420045505865
NIH Device Record Keyaaadee94-0849-4e1d-893a-cf1df992f0ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameHorizon Wi
Version Model NumberHorizon Wi
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 Batchfalse
Serial Numbertrue
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

Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 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
GS115420045505865 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-02
Device Publish Date2016-12-09

Devices Manufactured by Hologic, Inc.

15420045515529 - OMNI2024-02-27 The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a
15420045515734 - OMNI2024-02-27 The Omni Hysteroscopic Grasper is a sterile, single-use, hand actuated hysteroscopic grasper that is intended to be used by a tr
15420045515161 - Brevera Breast Biopsy System2024-02-23 Reusable Driver
45420045505279 - Fluent Fluid Management System2023-12-27 The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hyster
45420045507662 - Fluent Fluid Management System2023-12-27 The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hyster
15420045510920 - Panther Fusion®2023-12-06 Specimen Transport Medium.
15420045510463 - Panther Fusion®2023-11-30 Panther Fusion® Extraction Reagent-X.
15420045510906 - Panther Fusion®2023-11-29 Panther Fusion® GBS Controls Kit.

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