FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857031581
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703158
Catalog number
5703158
Device description
Pack Ortho F/ Surg Center of Greenbelt
Published
2022-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857031585PrimaryHIBCC0
H65857031581Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

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Primary DI, Brand, Company table
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10198956439726CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956442450CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16