FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106053430
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
28-8920E
Catalog number
28-8920E
Device description
PACK PROC ARTHROGRAM IHC
Published
2022-12-09
Public version status
New
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
OIIArthrogram tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIIArthrogram TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106053438PackageGS118In Commercial Distribution
10197106053430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710605343850197106053438
1019710605343010197106053430

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 Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
10198956512474CARDINAL HEALTHCardinal Health 200, LLCOII2026-10-01
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