FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956436220
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
27-6416M
Catalog number
27-6416M
Device description
MYELOGRAM TRAY
Published
2026-06-01
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
OIPRadiology-diagnostic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956436228PackageGS120In Commercial Distribution
10198956436220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895643622850198956436228
1019895643622010198956436220

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.

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
10198956491526CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956527959CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956525252CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-06
10198956498693CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-08
10198956479449CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-05
10198956473911CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10198956484696CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10197106094143CARDINAL HEALTHCardinal Health 200, LLCOIP2024-01-10
10197106207574CARDINAL HEALTHCardinal Health 200, LLCOIP2023-09-27
10195594704599CARDINAL HEALTHCardinal Health 200, LLCOIP2023-06-01
10197106227787CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-31
10197106242605CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-18
10195594763831CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-16
10197106260289CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-03
10197106230695CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-25
10197106252574CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-25
10197106226872CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-20
10197106211441CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
10197106213117CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
10197106207680CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-03
10197106184530CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-21
10197106102053CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-15
10197106107928CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-10
10197106050521CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-08
10197106148761CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-02
10197106098493CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
10197106165652CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
10197106145982CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-23
10197106061718CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-16
10197106089743CARDINAL HEALTHCardinal Health 200, LLCOIP2023-01-30