DEVICE: REVAREE (08032595871064)

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Device Record History
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Device Identifier (DI) Information
REVAREE
VAGINAL SUPPOSITORIES 2 g
In Commercial Distribution

FARMA DERMA SRL
08032595871064
GS1

10
541677746 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
47673 Vaginal mucosa protection suppository
A device in the form of a tablet, ovule or gel that is inserted into the vagina containing compounds [e.g., hyaluronic acid (HA), plant oil extracts, vitamins] intended to promote and/or expedite the healing, re-epithelialization, and/or soothing of injured, atrophic, or irritated vaginal mucosa through various mechanisms (e.g., osmotic properties, lubrication). It is typically used for procedure-related injury (e.g., after childbirth, surgery, radiation), age-related dryness, or various pathologies (e.g., vulvovaginitis). It is intended for use in the home or healthcare facility. After application, this device cannot be reused.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
NUC Lubricant, Personal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K153372 000
No 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
807d4b01-84c8-4ee8-95c7-f046b89d0e63
August 20, 2020
4
February 26, 2018
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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: 08032595871088 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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