DEVICE: Reia (00860012119370)

Device Identifier (DI) Information

Reia
AA01-2
In Commercial Distribution

Reia, LLC
00860012119370
GS1

1
081063360 *Terms of Use
Size 2 Applicator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
32652 Vaginal applicator, reusable
A device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HGD Applicator, Vaginal
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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

01a269c9-24e9-4303-a2ab-e0dd996fe39e
July 30, 2024
1
July 22, 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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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