DEVICE: Preat (00842092166321)

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Device Record History
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Device Identifier (DI) Information
Preat
0200020
In Commercial Distribution
0200020
Preat Corporation
00842092166321
GS1

1
117776048 *Terms of Use
Pozi Pins
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
16701 Dental restoration retention pin kit
A collection of various dental instruments, devices and materials intended for the insertion of permanent pins in healthy dentin to provide retention and/or stabilization of dental restorations such as fillings and crowns. It is typically presented as a kit and contains, e.g., retention pins of incrementing sizes, a selection of dental drills, and the necessary instruments to facilitate the procedure. This is a reusable device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NDP Accessories, implant, dental, endosseous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
a92dbd86-6d29-482c-b6f0-1750c739a46f
January 11, 2024
3
October 24, 2022
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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
00842092172438 10 00842092166321 In Commercial Distribution Pack
00842092176030 1000 00842092166321 In Commercial Distribution Pack
00842092172445 25 00842092166321 In Commercial Distribution Pack
00842092172452 5 00842092166321 In Commercial Distribution Pack
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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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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