FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956561748
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN32MYM20
Catalog number
SAN32MYM20
Device description
MYELOGRAM WITHOUT NDL PACK
Published
2026-08-26
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
50198956561746PackageGS110In Commercial Distribution
10198956561748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656174650198956561746
1019895656174810198956561748

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 Temperature00

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956582316CARDINAL HEALTHCardinal Health 200, LLCOIP2026-09-29
10198956586369CARDINAL HEALTHCardinal Health 200, LLCOIP2026-09-29
10198956507135CARDINAL HEALTHCardinal Health 200, LLCOIP2026-09-22
10198956545496CARDINAL HEALTHCardinal Health 200, LLCOIP2026-08-17
10198956458482CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-27
10198956507074CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-27
10198956421226CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-20
10198956494749CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-20
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
10198956436220CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
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
10195594763831CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-16
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