ThinPrep Imaging System

Primary DI
15420045500891
Brand
ThinPrep Imaging System
Company
Hologic, Inc.
Model
ThinPrep Imaging System Review Scope
Catalog number
71062-001
Device description
A microscope used to screen ThinPrep® pap test slides that have been imaged by a ThinPrep® Image Processor.
Published
2014-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNMREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNMReader, Cervical Cytology Slide, AutomatedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020002007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020002007THINPREP (R) IMAGING SYSTEMHologic, Inc.2003-06-06MNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550089115420045500891

GMDN Terms#

Term, Definition table
TermDefinition
Basic light microscopeA magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius32 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Serial number
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15420045515062ThinPrep Imaging SystemHologic, Inc.MNM2022-08-24
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00382904914646BD FocalPoint Slide ProfilerBECTON, DICKINSON AND COMPANYMNM2019-12-03
15420045512511ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
15420045512535ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
00382904910907BD FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2019-06-27
15420045508156ThinPrep Imaging SystemHologic, Inc.MNM2018-10-13
15420045508040ThinPrep Imaging SystemHologic, Inc.MNM2018-05-23
15420045508163Thinprep Imaging SystemHologic, Inc.MNM2017-10-13
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15420045507258ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
15420045507265ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
00382904910853BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
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00382904910877BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
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