FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956578890
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT55CSKMD
Catalog number
SOT55CSKMD
Device description
CYSTO PACK MAUI
Published
2026-10-23
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956578898PackageGS13In Commercial Distribution
10198956578890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895657889850198956578898
1019895657889010198956578890

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160395744CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-10-24
10653160395751MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395799MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395850MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395867MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395881MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10653160395959MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-24
10198956433113CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956460942CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956544123CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956556065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956557055CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956557642CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956562745CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956571129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956577565CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956577589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956578951CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956579118CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956583863CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956584709CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956585591CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956586727CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956586956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956590939CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956591776CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956595781CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956601079CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956602182CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23
10198956602458CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-23