FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040058944
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1127139
Catalog number
1127139
Device description
Endo Organizer Foam Inserts
Published
2020-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040058944PrimaryGS10
00304040058947Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404005894410304040058944
00304040058947003040400589473040400589470304040058947

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic instrument-holding insert, single-useA device intended to be fitted into an endodontic instrument holder housing and used chairside during a dental endodontic procedure to hold and temporarily store sharp endodontic instruments (e.g., files/rasps). It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
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

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Primary DI, Brand, Company table
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00810212935539SURGIPROSSurgipros, LLCFTY2026-07-28
B382SD913261200Surgical DirectSurgical Direct, Inc.FTY2026-07-23
B382SD9132841000Surgical DirectSurgical Direct, Inc.FTY2026-07-23
10609576150064Puritan®Puritan Medical ProductsFTY2026-07-20
04719846017436CharderCHARDER ELECTRONIC CO., LTD.FTY2026-07-14
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08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
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G4250020My MedicalMy Medical Store LLCFTY2026-05-04
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00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
00887868287510Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-12
08809986680198Magic RulerInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)FTY2025-10-30
09348215165192Tendon RulerSIGNATURE ORTHOPAEDICS PTY LTDFTY2025-10-10
G79151202DMD000G0WishFIXRed Star Contract Manufacturing Inc.FTY2025-10-06