FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106600368
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN55OSNMC
Catalog number
SEN55OSNMC
Device description
ROQUE ORAL SURGERY PACK
Published
2024-04-10
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
50197106600366PackageGS18In Commercial Distribution
10197106600368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710660036650197106600366
1019710660036810197106600368

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.

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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