FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106953655
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
31-826AC
Catalog number
31-826AC
Device description
BONE MARROW BIOPSY TRAY
Published
2025-02-28
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
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
50197106953653PackageGS116In Commercial Distribution
10197106953655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710695365350197106953653
1019710695365510197106953655

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956419681CARDINAL HEALTHCardinal Health 200, LLCPXO2026-04-21
10198956418493CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-26
10198956413627CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-16
50198956413625CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-16
10198956388291CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-03
50198956388299CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-03
10198956357877CARDINAL HEALTHCardinal Health 200, LLCPXO2026-02-09
50198956357875CARDINAL HEALTHCardinal Health 200, LLCPXO2026-02-09
10198956220911CARDINAL HEALTHCardinal Health 200, LLCPXO2025-11-11
50198956220919CARDINAL HEALTHCardinal Health 200, LLCPXO2025-11-11
10198956194243CARDINAL HEALTHCardinal Health 200, LLCPXO2025-10-31
10198956163348CARDINAL HEALTHCardinal Health 200, LLCPXO2025-09-03
50198956163346CARDINAL HEALTHCardinal Health 200, LLCPXO2025-09-03
10198956094147CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-15
50198956094145CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-15
10198956131965CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-10
50198956131963CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-10
00849884006926VYGONVygon CorporationPXO2025-05-23
30849884006927VYGONVygon CorporationPXO2025-05-23
10198956056503CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-25
50198956056501CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-25
10197106956182CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-22
50197106956180CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-22
50197106953653CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-28
10197106927786CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-07
50197106927784CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-07
10197106878620CARDINAL HEALTHCardinal Health 200, LLCPXO2025-01-02
50197106878628CARDINAL HEALTHCardinal Health 200, LLCPXO2025-01-02
10197106801895CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-09
50197106801893CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-09