FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594712174
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN55OSTAB
Catalog number
SEN55OSTAB
Device description
CLINIC ORAL SURGERY PACK
Published
2022-06-24
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
50195594712172PackageGS12In Commercial Distribution
10195594712174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559471217250195594712172
1019559471217410195594712174

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

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
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