FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956170124
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENHDOSLGA
Catalog number
SENHDOSLGA
Device description
ORAL SURGERY PACK
Published
2025-08-19
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
50198956170122PackageGS11In Commercial Distribution
10198956170124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895617012250198956170122
1019895617012410198956170124

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia injection kitA collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956485242CARDINAL HEALTHCardinal Health 200, LLCPWL2026-05-25
10198956208735CARDINAL HEALTHCardinal Health 200, LLCPWL2025-10-13
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