FDA.reportPublic FDA data

Core Values

Primary DI
00017276226591
Brand
Core Values
Company
HARMON STORES, INC.
Model
017276226591
Device description
Rolled Gauze, roll, 4 IN x 2.5 YDS (101 mm x 2.28 m)
Published
2020-08-10
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
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10017276226598PackageGS172Not in Commercial Distribution
00017276226591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001727622659810017276226598
00017276226591000172762265910172762265910017276226591

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Regulatory Flags#

DUNS number
804085293
Device count
1
Premarket exempt
true
Lot or batch
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
00017276226607Core Values0172762266072020-08-10
00017276227963Core Values0172762279632020-08-10
00017276227970Core Values0172762279702020-08-10
00017276227987Core Values0172762279872020-08-10
00017276228595Core Values0172762285952020-08-10
00017276229745Core Values0172762297452020-08-10
00017276229752Core Values0172762297522020-08-10

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