DEVICE: Amoils Epithelial Scrubber (00628693343107)

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Device Record History
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Device Identifier (DI) Information
Amoils Epithelial Scrubber
Amoils Power Handle, Neck & Charger - Kit (230V)
In Commercial Distribution
AM1EXPH1
Innova Medical Ophthalmics Inc
00628693343107
GS1

1
249464702 *Terms of Use
Amoils Power Handle, Neck & Charger - Kit (230V)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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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?
42443 Corneal bur system, battery-powered
An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HOG Burr, Corneal, Battery-Powered
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K962989 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
97bc67ba-872c-4bd7-aa62-3ac9d906aed2
November 08, 2024
1
October 31, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
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Customer Contact

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No Customer Contact currently defined
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