FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857032025
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703202
Catalog number
5703202
Device description
Pack Surgical Pain F/ Advanced Ambulatory Surgery Center
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857032025PrimaryHIBCC0
H65857032021Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
5
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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10198956538818CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956554610CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956564138CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956549616CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-26
10198956547360CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956551442CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956394773CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956533066CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956461734CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956511798CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956524651CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956530706CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531024CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531031CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956435728CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956524613CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956518650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-16
10198956437500CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-09
10198956202320CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956381124CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956520196CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956381070CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-23
10198956486232CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-05
10198956454705CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-03
10198956405004CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-01
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25