FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956490949
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA45DCIMB
Catalog number
SMA45DCIMB
Device description
KIT SJB D AND C
Published
2026-07-06
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
PKFD and C tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKFD And C TrayUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956490947PackageGS14In Commercial Distribution
10198956490949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649094750198956490947
1019895649094910198956490949

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. 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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956423077CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956491823CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956497658CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-08
10198956442467CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956482302CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956490536CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956487567CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10198956488502CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10195594853969CARDINAL HEALTHCardinal Health 200, LLCPKF2022-11-16
10195594785321CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-27
10195594804152CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-06
10195594847876CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-29
10195594808365CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594830144CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594837433CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-20
10195594827236CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-14
10195594714628CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-09
10195594813642CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594821906CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594825508CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594809140CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594814847CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594803599CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-02
10195594790059CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-29
10195594783594CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-26
10195594789336CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594790950CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594792329CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594781392CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-17
10195594729929CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-12