FDA.reportPublic FDA data

Henry Schein

Primary DI
H65810463049
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1046304
Catalog number
1046304
Device description
Packing Strip Plain HSI
Published
2020-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65810463040PrimaryHIBCC0
H65810463049Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gauze stripA thin length of non-medicated sterile woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040199602Henry Schein570599457059942026-10-01
00304040199619Henry Schein570599557059952026-10-01
00304040199626Henry Schein570599657059962026-10-01
00304040199633Henry Schein570599757059972026-10-01
00304040199640Henry Schein570599857059982026-10-01
00304040199657Henry Schein570599957059992026-10-01
00304040199664Henry Schein570600057060002026-10-01
00304040199671Henry Schein570600157060012026-10-01
00304040199312Henry Schein570597057059702026-09-30
00304040199091Henry Schein570594357059432026-09-29
00304040199107Henry Schein570594657059462026-09-29
00304040199114Henry Schein570594457059442026-09-29
00304040199121Henry Schein570594757059472026-09-29
00304040199138Henry Schein570594557059452026-09-29
00304040199145Henry Schein570594857059482026-09-29
00304040199152Henry Schein570594957059492026-09-29
00304040199169Henry Schein570595157059512026-09-29
00304040199176Henry Schein570595057059502026-09-29
00304040199183Henry Schein570595257059522026-09-29
00304040199190Henry Schein570595357059532026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26