DEVICE: Satisfaite (00860000221511)
Device Identifier (DI) Information
Satisfaite
01
In Commercial Distribution
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FEMMEPHARMA CONSUMER HEALTHCARE LLC
01
In Commercial Distribution
01
FEMMEPHARMA CONSUMER HEALTHCARE LLC
Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Satisfaite is intended for ongoing use, not exclusively for use during intimate sexual activity. Satisfaite contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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60412 | Sexual lubricant |
A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NUC | Lubricant, Personal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K190752 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4372b597-2d66-4224-871d-93838fbbd176
August 07, 2020
2
June 16, 2020
August 07, 2020
2
June 16, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined