FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857030651
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703065
Catalog number
5703065
Device description
Tray Custom F/ Aspen Orthopedic Pain and Spine
Published
2022-04-29
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
H65857030655PrimaryHIBCC0
H65857030651Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
10
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
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
B098AMS17809A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-22
10809160527603HALYARDAVID MEDICAL, INC.OJH2026-07-21
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10198956301573CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956307438CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956316515CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956338326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956362208CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370456CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370982CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956372559CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956378421CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
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10198956422506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
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10198956455115CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460874CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956461994CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463110CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463127CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20