FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956604896
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBAW1RGMH1
Catalog number
SBAW1RGMH1
Device description
ROBOTIC GENERAL PACK
Published
2026-10-06
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956604894PackageGS13In Commercial Distribution
10198956604896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660489450198956604894
1019895660489610198956604896

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 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
10198956506121CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956599222CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956610231CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
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