DEVICE: Satisfaite (00860000221511)

Device Identifier (DI) Information

Satisfaite
01
In Commercial Distribution
01
FEMMEPHARMA CONSUMER HEALTHCARE LLC
00860000221511
GS1

1
116647151 *Terms of Use
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.
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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?
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.
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 [?]
K190752 000
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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

4372b597-2d66-4224-871d-93838fbbd176
August 07, 2020
2
June 16, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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