DEVICE: ThinPrep 2000 Processor (15420045507005)

Device Identifier (DI) Information

ThinPrep 2000 Processor
ThinPrep 2000 Processor
In Commercial Distribution
PRD-04184
Hologic, Inc.
15420045507005
GS1

1
018925968 *Terms of Use
Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
15110 Microscope slide maker IVD
An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue, cytology specimens, or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MKQ Processor, cervical cytology slide, automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P950039 032
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 20 and 32 Degrees Celsius
Storage Environment Temperature: between -28 and 32 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9953c673-08f3-4fe4-b2c1-a10f386acfbb
November 07, 2024
6
March 10, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)442-9892
CustomerSupport@hologic.com
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