DEVICE: Brasseler USA (00887919769118)

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Device Record History
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Device Identifier (DI) Information
Brasseler USA
5025412RF
In Commercial Distribution

Peter Brasseler Holdings, LLC
00887919769118
GS1

1
082080136 *Terms of Use
ENDOSYNC A.I.1P
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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?
16355 Endodontic apex locator
A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LQY Locator, root apex
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K090925 000
No 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
e1afad6b-3da0-4a90-907d-790325009c6c
December 15, 2022
1
December 07, 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
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

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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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