FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956163348
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
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

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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
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
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
50197106801893CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-09