FDA.reportPublic FDA data

Healqu

Primary DI
00819143021038
Brand
Healqu
Company
Healqu LLC
Model
9022922
Device description
Healqu Bordered Gauze Dressing 2 x2
Published
2023-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819143025227PackageGS150In Commercial Distribution
00819143025234PackageGS190In Commercial Distribution
00819143025487PackageGS150In Commercial Distribution
00819143025494PackageGS190In Commercial Distribution
10819143021035PackageGS150In Commercial Distribution
20819143021032PackageGS190In Commercial Distribution
00819143021038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819143025227008191430252278191430252270819143025227
00819143025234008191430252348191430252340819143025234
00819143025487008191430254878191430254870819143025487
00819143025494008191430254948191430254940819143025494
1081914302103510819143021035
2081914302103220819143021032
00819143021038008191430210388191430210380819143021038

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Regulatory Flags#

DUNS number
080712881
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819143020888Healqu90209012023-11-08
00819143020918Healqu90209152023-11-09
00819143021373Healqu90242662023-11-09
00819143025241HealquUS-90227211-22025-07-10
00819143026347HealquUS-902274112026-03-05
00819143021052Healqu9022944-302023-11-08
00819143021069Healqu9022966-302023-11-08
00819143020925Healqu90209052023-11-08
00819143026446HealquUS-902272112026-03-05
00819143021335Healqu90241442023-11-09
00819143026354HealquUS-902274112026-03-05
00819143026453HealquUS-902272112026-03-05
00819143026293HealquUS-90227411-22026-02-19
00819143026309HealquUS-90227411-22026-02-19
00819143021342Healqu90241662023-11-09
00819143021366Healqu90242442023-11-09
00819143021359Healqu90242222023-11-09
00819143025340HealquUS-902276112025-08-21
00819143025685HealquCA-90227211-22025-08-21
00819143025722HealquCA-902274112025-08-21

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