FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439312331
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENDHDPNH3
Catalog number
SENDHDPNH3
Device description
DENTAL PACK
Published
2018-12-21
Public version status
Update
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
OFXGeneral purpose dental tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439312339PackageGS16In Commercial Distribution
10888439312331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843931233950888439312339
1088843931233110888439312331

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956464223CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-05
08720892104809Crown Cassette 200Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104823Crown Cassette 100Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104847Crown Cassette 300Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104861Crown Cassette 400Rademaker Medical Instruments B.V.OFX2026-06-04
10198956480858CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-01
10195327485092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587444Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327593520Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327608170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327628604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327654252Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
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10195327671136Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327674175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-04-07
10195327640170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
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10195327640408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327641399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327619978Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-11
10195327588168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07
10195327592608Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07
10195327582005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-31
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10195327469184Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21
10195327469306Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21
10195327489366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21
10195327493417Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21