RAEL

Basic Information

• Brand Name: RAEL
• Primary DI: 00856032008954
• Version / Model: Cardboard Applicator Super - Bulk
• Company Name: RAEL INC
• Labeler DUNS: 087378348
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1540
• Record Status: Published
• Publish Date: 2019-05-17
• Public Version: 3
• Public Version Date: 2023-03-28
• Public Version Status: Update
• Public Device Record Key: 0184de8a-e0e5-45a4-b078-c333603cc2d3
• Distribution End Date: 2021-12-01

Device Description

Organic cotton cardboard applicator tampons, super absorbency. 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	00856032008954	GS1
Unit of Use	00856032008978	GS1