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

Basic Information

• Brand Name: Pre-Seed™ Personal Lubricant Fertility Friendly Pre-filled Applicators
• Primary DI: 00055114999061
• Version / Model: 00055114999061
• Company Name: CHURCH & DWIGHT CO., INC.
• Labeler DUNS: 001211952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-07
• Public Version: 5
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: 5053677f-cbd8-4112-8786-7bdddccffe7c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEB	Lubricant, personal, gamete, fertilization, and embryo compatible	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00055114999061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K072741	000