FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956094145
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
31-826AF
Catalog number
31-826AF
Device description
BONE MARROW BIOPSY TRAY
Published
2025-07-15
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
PXOBone marrow biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXOBone Marrow Biopsy TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956094145PackageGS116In Commercial Distribution
10198956094147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895609414550198956094145
1019895609414710198956094147

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

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
50198956413625CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-16
50198956388299CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-03
50198956357875CARDINAL HEALTHCardinal Health 200, LLCPXO2026-02-09
50198956220919CARDINAL HEALTHCardinal Health 200, LLCPXO2025-11-11
50198956163346CARDINAL HEALTHCardinal Health 200, LLCPXO2025-09-03
50198956131963CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-10
30849884006927VYGONVygon CorporationPXO2025-05-23
50198956056501CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-25
50197106956180CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-22
50197106953653CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-28
50197106927784CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-07
50197106878628CARDINAL HEALTHCardinal Health 200, LLCPXO2025-01-02
50197106801893CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-09
50197106794935CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-04
50197106749362CARDINAL HEALTHCardinal Health 200, LLCPXO2024-09-19
50197106704507CARDINAL HEALTHCardinal Health 200, LLCPXO2024-07-10
50197106602704CARDINAL HEALTHCardinal Health 200, LLCPXO2024-06-21
50197106489015CARDINAL HEALTHCardinal Health 200, LLCPXO2023-12-29
B87534040Bone Access KitCustom Interventional Pain Management, LLCPXO2023-07-19
B875CTDLID0Bone Access KitCustom Interventional Pain Management, LLCPXO2023-07-19
B875TRAPLID0Bone Access KitCustom Interventional Pain Management, LLCPXO2023-07-19
50197106364701CARDINAL HEALTHCardinal Health 200, LLCPXO2023-07-06
50197106105076CARDINAL HEALTHCardinal Health 200, LLCPXO2023-02-23
50197106007974CARDINAL HEALTHCardinal Health 200, LLCPXO2022-11-29
50195594895370CARDINAL HEALTHCardinal Health 200, LLCPXO2022-11-07
50195594848604CARDINAL HEALTHCardinal Health 200, LLCPXO2022-10-11
50195594767134CARDINAL HEALTHCardinal Health 200, LLCPXO2022-09-08
50195594787019CARDINAL HEALTHCardinal Health 200, LLCPXO2022-09-02
M75257030911Stradis STRADIS MEDICAL, LLCPXO2022-08-09
M75257030920Stradis STRADIS MEDICAL, LLCPXO2022-07-28