FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956458680
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN21DIFCA
Catalog number
SEN21DIFCA
Device description
DENTAL IMPACTION PACK
Published
2026-06-01
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
OFYDental implant surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956458688PackageGS12In Commercial Distribution
10198956458680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895645868850198956458688
1019895645868010198956458680

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
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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116778662Zygomatic Surgical Kit, Standard Hex ADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-04-19
07290116770369Zygomatic surgical Kit, Standard Hex – TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-03-26
07290109308630Single TMA Open Tray TransferADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290109309927Guided Surgery Drills TRAYADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770000Guided Surgery Accessories TRAY– UNP&NPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770017Guided Surgery Accessories TRAY - RS ImplantsADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770024Guided Surgery Accessories TRAY– RP&WPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770291Guided Surgery Accessories KIT - UniFit Implants, TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772769Bone Autografting Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772776Bone Autografting Master SS Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772783OsseoSave Master NC Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772790OsseoSave Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116775494SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776507SS SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776514 SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776521SS SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116772967Bone Autografting Master SS Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773124OsseoSave Master Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773285OsseoSave Master NC Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116772806Bone Autografting Master KitADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-25
07640149888270TRITRI Dental Implants Int. AGOFY2025-11-10
07640149888324TRITRI Dental Implants Int. AGOFY2025-11-10
08435389826576COMPLETE SURGICAL BOX ADVANCED KITBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08435389828945STOP & GUIDE KIT; INTERNA IMPLANT; 3.0 PLATFORMBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08809918259980Surgical Option KitOssvis Co., Ltd.OFY2025-02-25
08435451660466KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660473KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660480KLOCKNERSOADCO, S.L.OFY2025-02-14
08809918259959Surgical Master Kit2Ossvis Co., Ltd.OFY2024-11-22
08809918259928Surgical Simple Kit2Ossvis Co., Ltd.OFY2024-10-25