FDA.reportPublic FDA data

Troubless

Primary DI
08809573486004
Brand
Troubless
Company
FARMSKIN Inc.
Model
Troubless MICRO-POINT PATCH
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809573486004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809573486004088095734860048809573486004

GMDN Terms#

Term, Definition table
TermDefinition
Skin semi-occlusive dressing, antimicrobialA substance (e.g., gel, cream, ointment) intended to be topically applied to injured/diseased skin to expedite skin healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the wound to the environment by means of a physical barrier; it also includes an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds (e.g., abrasions, lacerations, burns, surgical wounds, ulcers) and/or conditions (e.g., eczema, psoriasis, scars). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-243-7218cs.us@cdri.pro

Regulatory Flags#

DUNS number
694867229
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809573487322TroublessTroubless MICRO-POINT PATCH PLUS LIMITED VALUE PAC2024-11-11
08809573486479TroublessTroubless INVISIBLE PLUS SPOT PATCH THE CLASSIC2024-11-04
08809573486486TroublessTroubless INVISIBLE PLUS SPOT PATCH THE SIGNATURE2024-11-04
08809573487315TroublessTroubless INVISIBLE PLUS SPOT PATCH THE RED CORREC2024-11-04

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