FDA.report

TopCare health

Primary DI
10036800347301
Brand
TopCare health
Company
TOPCO ASSOCIATES, LLC
Model
036800347304
Device description
Antibacterial Sheer Bandages, assorted, 1 IN x 3 IN (2.5 cm x 7.6 cm); 3/4 IN x 3 IN (1.9 cm x 7.6 cm)
Published
2020-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10036800347301PackageGS172In Commercial Distribution
00036800347304PrimaryGS10
60036800347306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680034730110036800347301
00036800347304000368003473040368003473040036800347304
6003680034730660036800347306

GMDN Terms

TermDefinition
Skin-cover adhesive strip, antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18884230139topcare@topco.com

Regulatory Flags

DUNS number
072943876
Device count
20
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10036800024899TopCare health0368000248922026-02-05
10036800024905TopCare health0368000249082026-01-30
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
10036800018836TopCare HealthDigital Wide-Tip Pregnancy TestN/A2025-03-03
10036800092508TOPCARE87-621-00087-621-0002016-09-12
10036800118123TOPCARE87-207-00087-207-0002016-09-12
10036800216584TopCare health0368002165872019-07-31
10036800216591TopCare health0368002165942019-07-31
10036800216607TopCare health0368002166002019-07-31
10036800232690TOPCARE87-691-00187-691-0012016-09-12
10036800232706TOPCARE87-605-00187-605-0012016-09-12
10036800232713TOPCARE87-736-00187-736-0012016-09-13
10036800250762TopCare Insulin Syringe0329122016-09-24
10036800250779TopCare Insulin Syringe0529122016-09-24
10036800250786TopCare Insulin Syringe1029122016-10-04
10036800250793TopCare Insulin Syringe0330082016-09-24
10036800250809TopCare Insulin Syringe0530082016-09-24
10036800250816TopCare Insulin Syringe1030082016-09-24
10036800250823TopCare Insulin Syringe0331082016-09-24
10036800250830TopCare Insulin Syringe0531082016-09-24

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