FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040022993
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1047369
Catalog number
1047369
Device description
Forcep Bozeman Sponge Cvd
Published
2019-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HDMPACKER, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDMPacker, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040022993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040022993003040400229933040400229930304040022993

GMDN Terms#

Term, Definition table
TermDefinition
Uterine packerA hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479143579McKessonMCKESSON MEDICAL-SURGICAL INC.HDM2020-05-04
00612479141933McKessonMCKESSON MEDICAL-SURGICAL INC.HDM2018-11-19
10885403043437V. MuellerSTERIS CORPORATIONHDM2018-08-30
10885403043444V. MuellerSTERIS CORPORATIONHDM2018-08-30
10381780487043Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487050Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487067Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487074Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308400Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308450Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308500Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308550Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10885403042126V. MuellerSTERIS CORPORATIONHDM2018-08-17
10381780409458Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409465Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409472Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409489Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409496Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780479468Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419461Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419511Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419561Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419661Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
H834308350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780438441Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780440734Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
H834MH76220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780416548Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30
H834V976220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30