FDA.report

CARDINAL HEALTH

Primary DI
50197106330478
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
28-6501A
Catalog number
28-6501A
Device description
ARTHROGRAM TRAY
Published
2023-07-31
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

Related Records

Product Codes

CodeName
OIIArthrogram tray

Product Code Classifications

CodeDeviceSpecialtyClass
OIIArthrogram TrayRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106330478PackageGS118In Commercial Distribution
10197106330470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710633047850197106330478
1019710633047010197106330470

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
50198956392098CARDINAL HEALTHCardinal Health 200, LLCOII2026-03-24
50198956255072CARDINAL HEALTHCardinal Health 200, LLCOII2026-03-19
50198956417920CARDINAL HEALTHCardinal Health 200, LLCOII2026-03-16
50198956375909CARDINAL HEALTHCardinal Health 200, LLCOII2026-03-09
50198956369601CARDINAL HEALTHCardinal Health 200, LLCOII2026-02-23
50198956315875CARDINAL HEALTHCardinal Health 200, LLCOII2026-02-09
50198956330854CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-26
50198956301007CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-22
50198956312706CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-22
50198956253689CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-16
50198956307009CARDINAL HEALTHCardinal Health 200, LLCOII2026-01-05
50198956291728CARDINAL HEALTHCardinal Health 200, LLCOII2025-12-31
50198956289305CARDINAL HEALTHCardinal Health 200, LLCOII2025-12-22
50198956204421CARDINAL HEALTHCardinal Health 200, LLCOII2025-11-28
50198956182781CARDINAL HEALTHCardinal Health 200, LLCOII2025-11-17
50198956222654CARDINAL HEALTHCardinal Health 200, LLCOII2025-11-13
50198956182989CARDINAL HEALTHCardinal Health 200, LLCOII2025-09-09
50198956189544CARDINAL HEALTHCardinal Health 200, LLCOII2025-09-08
50198956178456CARDINAL HEALTHCardinal Health 200, LLCOII2025-08-25
50198956081039CARDINAL HEALTHCardinal Health 200, LLCOII2025-08-19
50198956151275CARDINAL HEALTHCardinal Health 200, LLCOII2025-08-08
50198956033304CARDINAL HEALTHCardinal Health 200, LLCOII2025-08-07
50198956124705CARDINAL HEALTHCardinal Health 200, LLCOII2025-06-30
50198956111767CARDINAL HEALTHCardinal Health 200, LLCOII2025-06-11
50198956082142CARDINAL HEALTHCardinal Health 200, LLCOII2025-06-10
50198956088670CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-29
50198956090628CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-29
50198956096477CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-29
50197106917174CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-15
50198956076707CARDINAL HEALTHCardinal Health 200, LLCOII2025-05-14