FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956512474
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
28A5420I
Catalog number
28A5420I
Device description
ARTHROGRAM TRAY
Published
2026-10-01
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
OIIArthrogram tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIIArthrogram TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956512472PackageGS120In Commercial Distribution
10198956512474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651247250198956512472
1019895651247410198956512474

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
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
50885380050372CARDINAL HEALTHCA901YTHCA901YTH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956577718CARDINAL HEALTHCardinal Health 200, LLCOII2026-09-25
10198956320598CARDINAL HEALTHCardinal Health 200, LLCOII2026-09-22
10198956331891CARDINAL HEALTHCardinal Health 200, LLCOII2026-09-04
10198956539143CARDINAL HEALTHCardinal Health 200, LLCOII2026-07-31
10198956504042CARDINAL HEALTHCardinal Health 200, LLCOII2026-07-06
00849233013797Busse Hospital DisposablesROBERT BUSSE & CO., INC.OII2026-06-09
10198956483828CARDINAL HEALTHCardinal Health 200, LLCOII2026-06-03
10198956489011CARDINAL HEALTHCardinal Health 200, LLCOII2026-06-03
10198956490345CARDINAL HEALTHCardinal Health 200, LLCOII2026-06-03
10198956490369CARDINAL HEALTHCardinal Health 200, LLCOII2026-06-03
10197106030783CARDINAL HEALTHCardinal Health 200, LLCOII2023-05-23
10197106084434CARDINAL HEALTHCardinal Health 200, LLCOII2023-04-14
10197106093603CARDINAL HEALTHCardinal Health 200, LLCOII2023-04-07
10197106051030CARDINAL HEALTHCardinal Health 200, LLCOII2023-03-08
10197106013199CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-17
10197106098547CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-17
10197106098639CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-10
10197106059647CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-31
10195594700218CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-30
10197106043585CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-26
10195594766542CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-20
10195594878801CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-13
10197106061800CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-30
10195594879396CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-29
10197106073759CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-29
10197106078266CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-23
10197106038505CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-22
10197106059678CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-19
10195594835842CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-15
10197106059661CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-14