Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013354376

FEI Number

3013354376

Entity Name

Rael, Inc.

City/State/Country

Buena Park, CA, US

Establishment Address

6940 Beach Blvd. D-301, Buena Park, CA 90621, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Rael, Inc. (Owner Number: 10053897)

Owner / Operator Contact Address

6940 Beach Blvd. D-301, Buena Park, CA 90621, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rael Beauty Miracle Patch Invisible Spot Cover Rael Beauty Miracle Patch Spot Control Cover Rael Miracle Patch XL Spot control cover Rael Miracle Patch Overnight Spot Cover Rael MIRACLE PATCH DUO Invisible Spot Cover + Spot Control Cover Advanced Strength Retinol Spot Cover Rael Organic Cotton Reusable Pads (Pantyliners, Slim, Regular, Large, Overnight) Rael Reusable Period Underwear - High Waist - Small, Medium, Large, XLarge, XXLarge Rael Reusable Period Underwear - Bikini - Small, Medium, Large, XLarge, XXLarge Rael Reusable Period Underwear - Boyshorts - Small, Medium, Large, XLarge, XXLarge Rael Organic Cotton No-applicator Tampons - Regular 18 Rael Organic Cotton No-applicator Tampons - Super 18 Rael Compact Tampon Rael organic cotton pads - Regular Rael organic cotton pads - Overnight Rael organic cotton pads - Large Rael organic cotton pads - Petite Rael Organic Cotton Cover Period Underwear L-XL Rael Organic Panty Liner - Long Rael Organic Panty Liner - Regular Rael Organic Cotton Cover Pads - Extra Long Overnight Rael Micro Thin Organic Cotton Cover Daily Liners - Regular Rael Organic Cotton Cover Period Underwear S-M Rael Organic Cotton Cover Panty Liners Extra Long Rael Organic Cotton tampons with Plant-Based plastic Applicators- Regular+Super Rael Organic Cotton tampons with Plant-Based plastic Applicators- Super Rael Organic Cotton tampons with Plant-Based plastic Applicators- Regular Rael Organic Cotton Cover Incontinence Pads-Ultimate Rael Organic Cotton Cover Incontinence Pads-Moderate Rael Organic Cotton Cover Incontinence Liners-Regular Rael Organic Cotton Cover Incontinence Liners-Long Rael Beauty Miracle Patch Microcrystal Spot Cover Rael Miracle Patch Dark spot Cover 6ct Rael Organic Cotton Reusable Pads for Bladder Leaks (Slim, Medium, Large, Overnight) Rael Menstrual Cup Rael Tampon Rael Organic Cotton Cardboard Applicator Tampons - Super Rael Organic Cotton Cardboard Applicator Tampons - Regular Rael Natural Herbal Heating Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-07-24
NUQ	Pad, Menstrual, Reusable	Obstetrics/Gynecology	Class 1	884.5435	2017-03-10
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2017-11-30
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2019-12-09
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2017-03-10
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5460	2021-05-18
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2021-05-18
NXH	Nursing Pad, Cohesive Gel	General Hospital	Class 1	880.5630	2020-01-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-07-24
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2017-03-10
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2017-03-22
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2019-07-23
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2022-04-25
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-12-14

Official Correspondent

Binna Won

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rael, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013354376. Last updated year: 2026. Please use registration number 3013354376 when referencing this establishment in official correspondence.