ThinPrep Imaging System

GUDID 25420045501093

Hologic, Inc.

Cervical cytology microscopy slide IVD
Primary Device ID25420045501093
NIH Device Record Keyca8077f1-eecc-48de-bcb1-b650adecbcd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinPrep Imaging System
Version Model NumberThinPrep Imaging System Slides
Company DUNS018925968
Company NameHologic, Inc.
Device Count100
DM Exempttrue
Pre-market Exemptfalse
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 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
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 0 and 15 Degrees Celsius
Handling Environment TemperatureBetween 0 and 15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045501096 [Unit of Use]
GS125420045501093 [Primary]
GS135420045501090 [Package]
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKQProcessor, cervical cytology slide, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-11

On-Brand Devices [ThinPrep Imaging System]

25420045501093ThinPrep Imaging System Slides
15420045508163Thinprep Imaging System Computer
15420045508156ThinPrep Imaging System Server
15420045508040ThinPrep Imaging System Review Scope
15420045507265ThinPrep Imaging System Workstation
15420045507258ThinPrep Imaging System Workstation
15420045504103ThinPrep Imaging System Workstation
15420045504097ThinPrep Imaging System Workstation
15420045504080ThinPrep Imaging System Workstation
15420045504042ThinPrep Imaging System Computer
15420045504035ThinPrep Imaging System Workstation
15420045501041ThinPrep Imaging System Computer
15420045501034ThinPrep Imaging System Computer
15420045501027ThinPrep Imaging System Server
15420045501010ThinPrep Imaging System Server
15420045501003ThinPrep Imaging System Server
15420045500990ThinPrep Imaging System Workstation
15420045500983ThinPrep Imaging System Workstation
15420045500976ThinPrep Imaging System Workstation
15420045500945ThinPrep Imaging System Workstation
15420045500938ThinPrep Imaging System Imaging Station
15420045500921ThinPrep Imaging System Imaging Station
15420045500914ThinPrep Imaging System Imaging Station
15420045500907ThinPrep Imaging System Review Scope
15420045500891ThinPrep Imaging System Review Scope
15420045512535ThinPrep Imaging System Workstation
15420045512511ThinPrep Imaging System Workstation
15420045513716Thinprep Imaging System Computer
15420045515062ThinPrep Imaging System Computer

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