DEVICE: EarPro (05065006332208)

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Device Record History
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Device Identifier (DI) Information
EarPro
20ml
In Commercial Distribution
20
Liquidpro US
05065006332208
GS1

1
048485021 *Terms of Use
EarPro is a blend of medical grade mineral oil and premium organic oregano oil to combat problems related to water exposure in ears EarPro acts as a protective layer.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
46259 Moisture/lubrication otic oil
An oil-based substance intended to be applied to the external auditory canal of the ear to provide moisture and/or lubrication typically to facilitate softening and/or removal of ear wax, removal of impurities, barrier to external water, and/or loosening of encrustations; it may in addition have non-pharmaceutical antimicrobial and/or anti-inflammatory properties (e.g., oregano oil). It is typically available as a liquid to be applied as a spray or drops, and is normally available for use in the home by a layperson. After application, this device cannot be reused.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
NEC Bandage, Liquid, Skin Protectant
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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
Storage Environment Temperature: between 39 and 113 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
42ff0942-a714-4af6-aca1-244e1340f68b
April 03, 2024
2
November 28, 2023
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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