FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040196806
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5705849
Catalog number
5705849
Device description
HENRY SCHEIN PATIENT PACK VCU
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040196806PrimaryGS10
00304040196809Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404019680610304040196806
00304040196809003040401968093040401968090304040196809

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537855HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537862HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537879HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537886HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537893HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537909HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537916HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537923HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537930HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537947HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537954HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537961HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537985HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537992HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538005HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538029HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538036HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160538043HalyardAVID MEDICAL, INC.LRO2026-09-20
10809160537541HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537558HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537572HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537589HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537596HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537602HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537640HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537664HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537688HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537695HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537701HalyardAVID MEDICAL, INC.LRO2026-09-19
10809160537732HalyardAVID MEDICAL, INC.LRO2026-09-19