DEVICE: Pre-Seed™ Personal Lubricant Fertility Friendly (00855114000961)

Device Identifier (DI) Information

Pre-Seed™ Personal Lubricant Fertility Friendly
00855114000961
In Commercial Distribution

CHURCH & DWIGHT CO., INC.
00855114000961
GS1

1
001211952 *Terms of Use
1 tube, 9 applicators
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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
PEB Lubricant, personal, gamete, fertilization, and embryo compatible
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K072741 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

6f541066-d0b6-4a17-b5ee-d63d938e57e3
August 07, 2020
4
February 27, 2018
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)833-9532
Consumer.Relations@churchdwight.com
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