DEVICE: REVAREE PLUS (08032595872078)

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

FARMA DERMA SRL
08032595872078
GS1

3
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?
47899 Vaginal mucosa protection dressing
A substance (e.g., gel, cream, suppository) containing various compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to be applied in and around the vagina to: 1) promote and/or expedite the healing, re-epithelialization, and/or soothing/lubrication of dry, injured, atrophic, or irritated vaginal mucosa; and/or 2) function as barrier to prevent adherence of pathogenic microorganisms (especially mycotic) to the vulvo-vaginal mucosa. It is intended for use in the home or healthcare facility to manage procedure-related injury (e.g., childbirth, surgery, radiotherapy), menopause, or various pathologies (e.g., vulvovaginitis). After application, this device cannot be reused.
Active 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 [?]
K213220 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
006eeb1b-fe10-4d7b-b9a2-db03a2349df2
April 04, 2024
1
March 27, 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: 08032595871958 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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