FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106591589
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA35ASFSA
Catalog number
SMA35ASFSA
Device description
ASPIRATION PACK
Published
2024-04-05
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
OJTAspiration tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJTAspiration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106591589PackageGS15In Commercial Distribution
10197106591581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710659158950197106591589
1019710659158110197106591581

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
50198956408096CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-23
50198956391954CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-19
50198956164015CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
50198956338553CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
50198956387391CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-23
50198956368048CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-13
50198956276015CARDINAL HEALTHCardinal Health 200, LLCOJT2025-12-09
50198956262780CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-13
50198956170085CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-11
50198956163865CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-05
50198956112115CARDINAL HEALTHCardinal Health 200, LLCOJT2025-07-28
50198956110074CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-13
50198956099744CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-10
50198956086515CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-05
50198956015911CARDINAL HEALTHCardinal Health 200, LLCOJT2025-03-31
50197106970629CARDINAL HEALTHCardinal Health 200, LLCOJT2025-02-26
50197106884094CARDINAL HEALTHCardinal Health 200, LLCOJT2025-01-13
50197106848508CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-25
50197106817443CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
50197106821211CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
50197106782307CARDINAL HEALTHCardinal Health 200, LLCOJT2024-10-03
50197106755479CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-30
50197106755097CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-28
50197106723430CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-26
50197106718177CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-16
50197106683154CARDINAL HEALTHCardinal Health 200, LLCOJT2024-06-18
50197106589784CARDINAL HEALTHCardinal Health 200, LLCOJT2024-06-12
50197106645794CARDINAL HEALTHCardinal Health 200, LLCOJT2024-04-29
50197106622542CARDINAL HEALTHCardinal Health 200, LLCOJT2024-04-04
50197106515974CARDINAL HEALTHCardinal Health 200, LLCOJT2024-03-08