Pre-Seed™ Personal Lubricant Fertility Friendly Pre-filled Applicators

GUDID 00055114999061

CHURCH & DWIGHT CO., INC.

Sexual lubricant

• Primary Device ID: 00055114999061
• NIH Device Record Key: 5053677f-cbd8-4112-8786-7bdddccffe7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Seed™ Personal Lubricant Fertility Friendly Pre-filled Applicators
• Version Model Number: 00055114999061
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00055114999061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072741

FDA Product Code

• PEB: Lubricant, personal, gamete, fertilization, and embryo compatible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-04-07

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