FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040059623
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1003048
Catalog number
1003048
Device description
Impulse Heat Sealer
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KSDDevice, heat-sealing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSDDevice, Heat-SealingHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040059623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040059623003040400596233040400596230304040059623

GMDN Terms#

Term, Definition table
TermDefinition
Package sealing unitA mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
Lot or batch
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
06976301910840YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910857YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910864YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910871YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-04-30
06976301910420YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910437YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910444YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910451YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910468YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910475YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910482YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910499YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910505YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910512YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910529YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910536YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910543YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910550YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
06976301910567YingtaiChangsha Yingtai Instrument Co., LtdKSD2025-03-01
03567050073097MACOSEAL LIGHTMACO PHARMAKSD2024-08-27
08033928530498ROMA Cordless handheld sealer for blood bag tubingDELCON SRLKSD2023-07-25
08033928530795ROMA ChargerDELCON SRLKSD2023-07-25
08033928530818HemoWeld-GunDELCON SRLKSD2023-07-25
03567050071970MacoSeal PS2-ASMACO PHARMAKSD2022-12-31
08033928530115HemoWeld-TDELCON SRLKSD2022-12-07
08033928530122HemoWeld-GunDELCON SRLKSD2022-12-07
08033928530139HemoWeld-GunDELCON SRLKSD2022-12-07
08033928530146HemoWeld Gun HandgunDELCON SRLKSD2022-12-07
08033928530153HemoWeld-BDELCON SRLKSD2022-12-07
08033928530160HemoWeld-SlimDELCON SRLKSD2022-12-07