FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956094529
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN55OSTAH
Catalog number
SEN55OSTAH
Device description
CLINIC ORAL SURGERY PACK
Published
2025-07-31
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
50198956094527PackageGS12In Commercial Distribution
10198956094529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895609452750198956094527
1019895609452910198956094529

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
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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956602472CARDINAL HEALTHCardinal Health 200, LLCPWL2026-10-23
D95516CASS1Paul BandittTerlain Enterprises, Inc.PWL2026-09-25
D9555CASS1Paul BandittTerlain Enterprises, Inc.PWL2026-09-25
D9558CASS1Paul BandittTerlain Enterprises, Inc.PWL2026-09-25
10198956485242CARDINAL HEALTHCardinal Health 200, LLCPWL2026-05-25
10198956208735CARDINAL HEALTHCardinal Health 200, LLCPWL2025-10-13
10198956170124CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19
50198956170122CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19
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