DEVICE: SectionStar (00198168976302)

Device Identifier (DI) Information

SectionStar
810-00001
Not in Commercial Distribution

Clarapath, Inc.
00198168976302
GS1
October 22, 2024
1
079469240 *Terms of Use
No description.
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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?
15158 Rotary microtome IVD
A precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IDO Microtome, Rotary
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

0f0c3e30-4811-486d-ba02-f3a094539d1f
October 23, 2024
2
August 16, 2024
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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

[?]
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)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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