FDA.report

TopCare health

Primary DI
10036800259772
Brand
TopCare health
Company
TOPCO ASSOCIATES, LLC
Model
036800259775
Device description
Hydrocolloid Blister Cushions, toes and heels, 1.65 IN x 2.67 IN (42 mm x 68 mm); 1.33 IN x 2.12 IN (34 mm x 54 mm); 0.66 IN x 2.32 IN (17 mm x 59 mm)
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
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10036800259772PackageGS112In Commercial Distribution
00036800259775PrimaryGS10
60036800259777Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680025977210036800259772
00036800259775000368002597750368002597750036800259775
6003680025977760036800259777

GMDN Terms

TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-sterileA non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) and/or minor abrasions by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
18884230139topcare@topco.com

Regulatory Flags

DUNS number
072943876
Device count
6
DM exempt
false
Premarket exempt
true
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 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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