FDA.reportPublic FDA data

Medrull - Ultra Pore - Adhesive Wound Dressing

Primary DI
00860012220311
Brand
Medrull - Ultra Pore - Adhesive Wound Dressing
Company
Overseas Consensus LLC
Model
Breathable 5x7cm N75
Device description
Self-adhesive sterile absorbent dressing made of soft non woven materials, is designed for low to moderately exuding wounds, such as surgical wounds, cuts and abrasions.
Published
2025-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00860012220311PrimaryGS10
00860012220359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012220311008600122203118600122203110860012220311
00860012220359008600122203598600122203590860012220359

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1-302-6650949vladislav@forans.lv

Regulatory Flags#

DUNS number
118986451
Device count
75
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012220328Medrull - Ultra Pore - Adhesive Wound DressingWaterproof 5x7cm N52025-04-17
00860012220335Medrull - Ultra Pore - Adhesive Wound DressingWaterproof 5x7cm N752025-04-17
00860012220342Medrull - Ultra Pore - Adhesive Wound DressingWaterproof 5x7cm N752025-04-17
00860012220304Medrull - Ultra Pore - Adhesive Wound DressingBreathable 5x7cm N52025-04-07
00860012220359Medrull - Ultra Pore - Adhesive Wound DressingBreathable 5x7cm N752025-04-07

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