FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439995549
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBAMHGLMH1
Catalog number
SBAMHGLMH1
Device description
MH GEN LAPAROSCOPY STD PACK
Published
2021-01-15
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439995549PackageGS12In Commercial Distribution
10888439995541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843999554950888439995549
1088843999554110888439995541

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956594845CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956596528CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956567597CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956568037CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956590243CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956591479CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956592773CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956593862CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956550483CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956587359CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956589254CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956589315CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956591240CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-25
10198956550452CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956555716CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956555938CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956558342CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956561892CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956587434CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-22
10198956581500CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10198956581586CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10198956583696CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-21
10809160536858HalyardMEDICAL ACTION INDUSTRIES INC.FDE2026-09-18
10198956398467CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956487468CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956555778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-04
10198956330221CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956547742CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956564473CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956556805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-18