FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956163346
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
31-826AG
Catalog number
31-826AG
Device description
BONE MARROW BIOPSY TRAY
Published
2025-09-03
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
50198956163346PackageGS116In Commercial Distribution
10198956163348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895616334650198956163346
1019895616334810198956163348

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956501768CARDINAL HEALTHCardinal Health 200, LLCPXO2026-06-23
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
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
10197106953655CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-28
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