FDA.reportPublic FDA data

MYBOXSHOP

Primary DI
00860178002608
Brand
MYBOXSHOP
Company
MYBOXSHOP, INC.
Model
860178002608
Device description
Applicator tampons S+
Published
2018-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRWScale, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151170000Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O.2015-07-02HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860178002608PrimaryGS10
00850002026016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860178002608008601780026088601780026080860178002608
00850002026016008500020260168500020260160850002026016

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081229542
Device count
16
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860178002615MYBOXSHOP8601780026152018-09-11
00860178002622MYBOXSHOP8601780026222018-09-11
00860178002639MYBOXSHOP8601780026392018-09-11
00860178002646MYBOXSHOP8601780026462018-09-11
00860178002653MYBOXSHOP8601780026532018-09-11
00860178002660MYBOXSHOP8601780026602018-09-11
00860178002684MYBOXSHOP8601780026842018-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04012030022927seca 406seca GmbH & Co. KGFRW2026-04-22
H933P11634Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FRW2025-12-03
04719846015753CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
04719846016040CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
40080196291237MEDLINEMEDLINE INDUSTRIES, INC.FRW2025-06-25
00860012873609WoddleWoddle Baby, Inc.FRW2025-06-02
10688503001051SavariaSavaria Concord LiftFRW2025-05-29
10688503001068SavariaSavaria Concord LiftFRW2025-05-29
00628725008264Smart ScaleCanadian Hospital Specialties LimitedFRW2025-02-28
00628725008271SMART SCALECanadian Hospital Specialties LimitedFRW2025-02-28
00093764604454A&D MedicalA&D COMPANY, LIMITEDFRW2024-10-16
04012030003711seca 206seca GmbH & Co. KGFRW2024-10-01
04012030003759seca 212seca GmbH & Co. KGFRW2024-10-01
04012030004381seca 206seca GmbH & Co. KGFRW2024-10-01
04012030007252seca 201seca GmbH & Co. KGFRW2024-10-01
04012030007269seca 201seca GmbH & Co. KGFRW2024-10-01
14012030003718seca 206seca GmbH & Co. KGFRW2024-10-01
14012030003756seca 212seca GmbH & Co. KGFRW2024-10-01
24012030004385seca 206seca GmbH & Co. KGFRW2024-10-01
14012030007259seca 201seca GmbH & Co. KGFRW2024-10-01
24012030007263seca 201seca GmbH & Co. KGFRW2024-10-01
05600494138736WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUSINVACARE CORPORATIONFRW2024-08-15
00732094251050Welch Allyn, Inc.WELCH ALLYN, INC.FRW2024-08-14
04012030021081seca 442seca GmbH & Co. KGFRW2024-05-07
04012030021470seca 495seca GmbH & Co. KGFRW2024-05-01
04012030021487seca 495 rseca GmbH & Co. KGFRW2024-05-01
04012030021494seca 496seca GmbH & Co. KGFRW2024-05-01
04012030021500seca 604seca GmbH & Co. KGFRW2024-05-01
04012030021593seca 404seca GmbH & Co. KGFRW2024-05-01
04012030021609seca 446seca GmbH & Co. KGFRW2024-05-01