FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956485242
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN55OSTAI
Catalog number
SEN55OSTAI
Device description
CLINIC ORAL SURGERY PACK
Published
2026-05-25
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
PWLOral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWLOral Surgery TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956485240PackageGS12In Commercial Distribution
10198956485242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648524050198956485240
1019895648524210198956485242

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, medicated, single-useA collection of various sterile dental/surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
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
true
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956170122CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19
50198956094527CARDINAL HEALTHCardinal Health 200, LLCPWL2025-07-31
05010058178137InstrapacROBINSON HEALTHCARE LIMITEDPWL2025-06-19
10840365900242InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365900518InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365900532InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365900723InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365900761InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901683InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901836InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901843InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901874InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901881InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901898InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901928InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901959InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365901997InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902178InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902239InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902253InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902260InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902277InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902291InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902321InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902352InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902468InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902741InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365902758InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365903137InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12
10840365903151InvenioGRI Medical & Electronic Technology Co., Ltd.PWL2025-03-12