FDA.reportPublic FDA data

Henry Schein

Primary DI
H65890043151
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004315
Catalog number
9004315
Device description
Strip Wound Closure Opague
Published
2021-07-22
Public version status
New
Distribution status
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
FPXStrip, adhesive, closure, skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPXStrip, Adhesive, Closure, SkinGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65890043152PackageHIBCC4In Commercial Distribution
H65890043151PrimaryHIBCC0
H65890043170Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closure adhesive stripA small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344203547CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203554CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203561CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203578CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203585CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
00050428344781CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFPX2026-05-25
30197344203530CURADMEDLINE INDUSTRIES, INC.FPX2026-05-15
00194346192038EquateWAL-MART STORES, INC.FPX2024-02-15
20194346192032EquateWAL-MART STORES, INC.FPX2024-02-15
10849233004822Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20849233004874Busse Hospital DisosablesROBERT BUSSE & CO., INC.FPX2023-06-16
10849233004884Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
10849233004891Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20849233005000Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
00017276239287Care ScienceAso LLCFPX2023-06-08
20017276239281Care ScienceAso LLCFPX2023-06-08
10665973008803DukalDukal LLCFPX2022-12-06
10665973008810DukalDukal LLCFPX2022-12-06
10665973008827DukalDukal LLCFPX2022-12-06
10665973008834DukalDukal LLCFPX2022-12-06
10665973008841DukalDukal LLCFPX2022-12-06
10665973008858DukalDukal LLCFPX2022-12-06
20665973008800DukalDukal LLCFPX2022-12-06
20665973008817DukalDukal LLCFPX2022-12-06
20665973008824DukalDukal LLCFPX2022-12-06
20665973008831DukalDukal LLCFPX2022-12-06
30665973008845DukalDukal LLCFPX2022-12-06
30665973008852DukalDukal LLCFPX2022-12-06
00840986021558Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21
10840986021555Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21