DEVICE: Pulse Aloe-ahh (00086700300021)

Device Identifier (DI) Information

Pulse Aloe-ahh
1
In Commercial Distribution

TOASTER LABS, INC.
00086700300021
GS1

1
079882181 *Terms of Use
Silicone based personal lubricant
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Sexual lubricant A non-sterile 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. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
NUC Lubricant, Personal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152671 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

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Size Type Text
No Device Sizes
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Device Record Status

83153f63-9c39-42a2-8194-e9121dfdae2e
August 09, 2018
4
January 03, 2017
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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