FDA.reportPublic FDA data

HSEU

Primary DI
00304040151402
Brand
HSEU
Company
HENRY SCHEIN, INC.
Model
5702543
Catalog number
5702543
Device description
20% ferric sulfate gel used for immediate and profound control of bleeding. This gel works on both hard and soft tissue and is highly effective for the control of bleeding during impressions, restorations, and crown and bridge procedures.
Published
2021-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MVLCORD, RETRACTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040151409PackageGS120In Commercial Distribution
00304040151402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404015140910304040151409
00304040151402003040401514023040401514020304040151402

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction solutionA liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2-30C
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
012430880
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809370410080SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410097SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410219SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410226SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410233SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410240SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410257SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410332SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410363SMARTCORDEASTDENT CO., LTDMVL2026-10-01
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00883205043238ViscoStat ClearULTRADENT PRODUCTS, INC.MVL2026-08-22
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00883205043252ViscoStat ClearULTRADENT PRODUCTS, INC.MVL2026-08-22
J014660872140Retraxil blueKulzer GmbHMVL2026-04-21
J014660872150Retraxil blueKulzer GmbHMVL2026-04-21
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J014661012770Retraxil blueKulzer GmbHMVL2026-04-21
J014661012780Retraxil blueKulzer GmbHMVL2026-04-21
00850079280274Sure CordHexa DentalMVL2026-03-04
00008579280274sure EndoHexa DentalMVL2026-01-22
00850079280182Sure EndoHexa DentalMVL2026-01-22
00850079280199Sure EndoHexa DentalMVL2026-01-22
00850079280205Sure endoHexa DentalMVL2026-01-22
00850079280212Sure EndoHexa DentalMVL2026-01-22
00850079280229Sure endoHexa DentalMVL2026-01-22
00850079280236Sure EndoHexa DentalMVL2026-01-22
00850079280243Sure EndoHexa DentalMVL2026-01-22