FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956584228
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32A5384G
Catalog number
32A5384G
Device description
FNA PACK
Published
2026-09-29
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
50198956584226PackageGS120In Commercial Distribution
10198956584228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658422650198956584226
1019895658422810198956584228

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956496552CARDINAL HEALTHCardinal Health 200, LLCOJT2026-06-08
10198956383265CARDINAL HEALTHCardinal Health 200, LLCOJT2026-04-28
10198956458642CARDINAL HEALTHCardinal Health 200, LLCOJT2026-04-27
10198956408098CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-23
10198956391956CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-19
10198956164017CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
10198956338555CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
10198956387393CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-23
10198956368040CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-13
10198956276017CARDINAL HEALTHCardinal Health 200, LLCOJT2025-12-09
10198956162525CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-19
10198956262782CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-13
10198956240209CARDINAL HEALTHCardinal Health 200, LLCOJT2025-10-23
10198956170087CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-11
10198956163867CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-05
10198956112117CARDINAL HEALTHCardinal Health 200, LLCOJT2025-07-28
10198956110076CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-13
10198956099746CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-10
10198956086517CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-05
10198956015913CARDINAL HEALTHCardinal Health 200, LLCOJT2025-03-31
10197106970621CARDINAL HEALTHCardinal Health 200, LLCOJT2025-02-26
10197106884096CARDINAL HEALTHCardinal Health 200, LLCOJT2025-01-13
10197106848500CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-25
10197106817445CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
10197106821213CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
10197106782309CARDINAL HEALTHCardinal Health 200, LLCOJT2024-10-03
10197106755471CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-30
10197106755099CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-28
10197106723432CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-26
10197106718179CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-16