FDA.reportPublic FDA data

Core Values

Primary DI
00017276235340
Brand
Core Values
Company
HARMON STORES, INC.
Model
017276235340
Device description
Advanced Waterproof, Fast Healing Hydrocolloid Gel Pad Bandages, all one size, 2 IN x 3 IN
Published
2019-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

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
10017276235347PackageGS172Not in Commercial Distribution
00017276235340PrimaryGS10
60017276235342Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001727623534710017276235347
00017276235340000172762353400172762353400017276235340
6001727623534260017276235342

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
804085293
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276223798Core Values0172762237982020-08-10
00017276223828Core Values0172762238282020-08-10
00017276224702Core Values0172762247022020-08-10
00017276224719Core Values0172762247192020-08-10
00017276224900Core Values0172762249002020-08-10
00017276225402Core Values0172762254022020-08-10
00017276225747Core Values0172762257472020-08-10
00017276226485Core Values0172762264852020-08-10
00017276226492Core Values0172762264922020-08-10
00017276226515Core Values0172762265152020-08-10
00017276226522Core Values0172762265222020-08-10
00017276226546Core Values0172762265462020-08-10
00017276226553Core Values0172762265532020-08-10
00017276226591Core Values0172762265912020-08-10
00017276226607Core Values0172762266072020-08-10
00017276227963Core Values0172762279632020-08-10
00017276227970Core Values0172762279702020-08-10
00017276227987Core Values0172762279872020-08-10
00017276228595Core Values0172762285952020-08-10
00017276229745Core Values0172762297452020-08-10

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Primary DI, Brand, Company table
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