3Dimensions

GUDID 15420045510388

Hologic, Inc.

Stationary mammographic x-ray system, digital
Primary Device ID15420045510388
NIH Device Record Keyf9cb6dc5-beeb-4a7c-9a17-05e3f235f246
Commercial Distribution StatusIn Commercial Distribution
Brand Name3Dimensions
Version Model NumberASY-11748-2D
Company DUNS139534114
Company NameHologic, 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045510388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTEDigital breast tomosynthesis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-13
Device Publish Date2019-11-05

On-Brand Devices [3Dimensions]

15420045508033ASY-10636-3D
15420045508026ASY-10636-2D
15420045508019ASY-10559
154200455072963DIMENSIONS SOFTWARE
15420045507289INTELLIGENT 2D SOFTWARE
15420045507272CLARITY HD SOFTWARE
15420045510395ASY-11748-3D
15420045511897ASY-11748-CHD
15420045510388ASY-11748-2D

Trademark Results [3Dimensions]

Mark Image

Registration | Serial
Company
Trademark
Application Date
3DIMENSIONS
3DIMENSIONS
87243930 5771595 Live/Registered
Hologic, Inc.
2016-11-21

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