FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594742117
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
31-8831H
Catalog number
31-8831H
Device description
BONE MARROW BIOPSY TRAY
Published
2022-07-14
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
50195594742117PackageGS110In Commercial Distribution
10195594742119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559474211750195594742117
1019559474211910195594742119

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
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

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
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