FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594615923
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PE35DTCH3
Catalog number
PE35DTCH3
Device description
KIT, DENTAL
Published
2022-04-06
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
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
50195594615923PackageGS12In Commercial Distribution
10195594615925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559461592350195594615923
1019559461592510195594615925

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487093CARDINAL HEALTHCardinal Health 200, LLCOFX2026-05-25
50198956366891CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-23
50198956321296CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-19
50198956351705CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956351743CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-10
50198956214741CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-09
50198956355024CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-06
50198956334357CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336641CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-03
50198956336627CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956386998CARDINAL HEALTHCardinal Health 200, LLCOFX2026-03-02
50198956177091CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366457CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-23
50198956366884CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-13
50198956285253CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956345179CARDINAL HEALTHCardinal Health 200, LLCOFX2026-02-02
50198956199673CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-30
50197106904334CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-23
50198956103137CARDINAL HEALTHCardinal Health 200, LLCOFX2026-01-05
50198956267006CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-31
50198956288452CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-17
50198956210057CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-10
50198956217704CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956285031CARDINAL HEALTHCardinal Health 200, LLCOFX2025-12-09
50198956277593CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-28
50198956281576CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-25
50198956259179CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956266986CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956273199CARDINAL HEALTHCardinal Health 200, LLCOFX2025-11-17
50198956158120CARDINAL HEALTHCardinal Health 200, LLCOFX2025-09-29