COTTON HIGH TECH SL

Basic Information

• Brand Name: COTTON HIGH TECH SL
• Primary DI: 08432984001247
• Version / Model: Cardboard applicator tampons REGULAR
• Company Name: COTTON HIGH TECH SL
• Labeler DUNS: 476370908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1920
• Record Status: Published
• Publish Date: 2017-01-25
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 810a7f6f-7765-4859-ae19-c1cd0191662b

Device Description

Organic cotton tampons distributed in bulk

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	884.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08432984001247	GS1
Unit of Use	08432984001308	GS1

Customer Contacts

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