FDA.reportPublic FDA data

Henry Schein

Primary DI
H658890044541
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004455
Catalog number
9004455
Device description
Retreat Hemostatic Solution
Published
2020-04-21
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
H658890044541PrimaryHIBCC0
H658890044549Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius29 Degrees Celsius

Regulatory Flags#

DUNS number
012430880
Device count
25
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J014660872140Retraxil blueKulzer GmbHMVL2026-04-21
J014660872150Retraxil blueKulzer GmbHMVL2026-04-21
J014661012760Retraxil blueKulzer GmbHMVL2026-04-21
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
00850079280250Sure EndoHexa DentalMVL2026-01-22
00850079280267Sure EndoHexa DentalMVL2026-01-22
00850079280281SDure endoHexa DentalMVL2026-01-22
00850079280175Sure EndoHexa DentalMVL2026-01-21
10818207024968Traxodent Gel AlCl - Bulk Syringe KitVista DentalMVL2025-06-30
10818207024975Traxodent Gel AlCl - Sample PackVista DentalMVL2025-06-30
10818207024982Traxodent Gel AlCl - Value PackVista DentalMVL2025-06-30
10818207024999Traxodent Gel AlCl - Refill KitVista DentalMVL2025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe KitVista DentalMVL2025-06-30
10818207025019Traxodent Gel FS - Value PackVista DentalMVL2025-06-30
10818207025026Traxodent Gel FS - Refill KitVista DentalMVL2025-06-30
00359883005665Tissue Goo™ Hemostatic Gel 4-PackDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe KitDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005634First String Advanced Braided Retraction Cord Non-Impregnated - SmallDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005641First String Advanced Braided Retraction Cord Non-Impregnated - MediumDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005658First String Advanced Braided Retraction Cord Non-Impregnated - LargeDEN-MAT HOLDINGS, LLCMVL2025-03-12