FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956208735
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PEHDOSV28
Catalog number
PEHDOSV28
Device description
KIT, ORP BASIC ORAL
Published
2025-10-13
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
PWLOral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWLOral Surgery TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956208733PackageGS12In Commercial Distribution
10198956208735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895620873350198956208733
1019895620873510198956208735

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956485242CARDINAL HEALTHCardinal Health 200, LLCPWL2026-05-25
10198956170124CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19
50198956170122CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19
10198956094529CARDINAL HEALTHCardinal Health 200, LLCPWL2025-07-31
50198956094527CARDINAL HEALTHCardinal Health 200, LLCPWL2025-07-31
05010058078130InstrapacROBINSON HEALTHCARE LIMITEDPWL2025-06-19
05010058178137InstrapacROBINSON HEALTHCARE LIMITEDPWL2025-06-19
00840365900245InvenioGri-Alleset, Inc.PWL2025-03-12
00840365900511InvenioGri-Alleset, Inc.PWL2025-03-12
00840365900535InvenioGri-Alleset, Inc.PWL2025-03-12
00840365900726InvenioGri-Alleset, Inc.PWL2025-03-12
00840365900764InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901686InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901839InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901846InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901877InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901884InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901891InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901921InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901952InvenioGri-Alleset, Inc.PWL2025-03-12
00840365901990InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902171InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902232InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902256InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902263InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902270InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902294InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902324InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902355InvenioGri-Alleset, Inc.PWL2025-03-12
00840365902461InvenioGri-Alleset, Inc.PWL2025-03-12