LOLA

Basic Information

• Brand Name: LOLA
• Primary DI: 00850017666887
• Version / Model: Washable Period Underwear Size Extra Extra Large
• Company Name: ALYK, INC.
• Labeler DUNS: 079830975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 1
• Public Version Date: 2022-07-18
• Public Version Status: New
• Public Device Record Key: 26a9b4c7-eab9-4073-8fe2-36fdf37d7035

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUQ	Pad, Menstrual, Reusable	Obstetrics/Gynecology	884.5435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66318	Menstrual underwear	A garment intended to be worn directly against the skin, in the same manner as conventional women's underwear, to absorb menstrual blood or other vaginal discharge. It is typically constructed of cotton, lycra and/or polyester with a leak-proof thermoplastic polyurethane (TPU) barrier. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017666887	GS1