DEVICE: Diva Lubricator (00841445001111)

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Device Record History
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Device Identifier (DI) Information
Diva Lubricator
1
In Commercial Distribution
FGBC200201
Diva International Inc
00841445001111
GS1

1
207651758 *Terms of Use
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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 [?]
K182027 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
cc62407e-06cd-420d-ba62-6363f84ae1b3
August 01, 2025
2
April 01, 2025
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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
10841445000692 6 00841445001111 In Commercial Distribution Case Pack
20841445000491 36 10841445000692 In Commercial Distribution Master Case
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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
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Customer Contact

[?]
18664443482
qaregulatory@divacup.com
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