TopCare Tampons

Primary DI
10036800426648
Brand
TopCare Tampons
Company
TOPCO ASSOCIATES, LLC
Model
BTCSGS18
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HILTampon, Menstrual, Scented, Deodorized

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIL Tampon, Menstrual, Scented, Scented-DeodorizedObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042773000ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONSRostam , Ltd.2004-11-23HIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00036800426641PackageGS16In Commercial Distribution
10036800426648PackageGS16In Commercial Distribution
00036800770218PrimaryGS10
07290016625165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00036800426641000368004266410368004266410036800426641
1003680042664810036800426648
00036800770218000368007702180368007702180036800770218
07290016625165072900166251657290016625165

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, scentedA non-sterile plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. It is scented for aesthetic and deodorizing purposes to counter odorous smells resulting from the discharge. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
072943876
Device count
18
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036800028326TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028333TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028340TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028357TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800216587TopCare health0368002165872019-07-31
00036800216600TopCare health0368002166002019-07-31
00036800413634TopCare health0368004136342019-10-31
00036800024892TopCare health0368000248922026-02-05
10036800024899TopCare health0368000248922026-02-05
00036800024908TopCare health0368000249082026-01-30
10036800024905TopCare health0368000249082026-01-30
00036800022683TopCare HealthTOP4045V2TOP4045V22026-01-27
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
20036800367436TopCare Premium Blood Glucose Meter8000-071642016-09-24
00036800250789TopCare Insulin Syringe1029122016-10-04
00036800250826TopCare Insulin Syringe0331082016-09-24
20036800367443TopCare Premium Blood Glucose Test Strips8000-071582016-09-24
20036800422159TopCare Premium Blood Glucose Test Strips8000-104432016-09-24
00036800250796TopCare Insulin Syringe0330082016-09-24
00036800250802TopCare Insulin Syringe0530082016-09-24

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