FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956614420
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PG40RBS24
Catalog number
PG40RBS24
Device description
KIT, ROBOTIC BARIATRIC
Published
2026-11-05
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
50198956614428PackageGS11In Commercial Distribution
10198956614420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895661442850198956614428
1019895661442010198956614420

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
10192253005820Monoject8602U8602U2026-11-05
10192253005837Monoject8605U8605U2026-11-05
10192253005844Monoject8607U8607U2026-11-05
10192253005851Monoject8611U8611U2026-11-05
10192253005868Monoject8612U8612U2026-11-05
10192253043112Argyle888830160688883016062026-08-12
10192253043136Argyle888830161488883016142026-08-12
10192253043143Argyle888830162288883016222026-08-12
10192253043181Argyle888830171388883017132026-08-12
10192253043198Argyle888830172188883017212026-08-12
10198956196308CARDINAL HEALTHPO44KLCSDPO44KLCSD2026-11-05
10198956202214CARDINAL HEALTHSBA11BCNMNSBA11BCNMN2026-11-05
10198956270817CARDINAL HEALTHSOP38THBADSOP38THBAD2026-11-05
10198956341296CARDINAL HEALTHSOPDKATCH7SOPDKATCH72026-11-05
10198956346659CARDINAL HEALTHPNV2LMA01CPNV2LMA01C2026-11-05
10198956347021CARDINAL HEALTHSCV5DOVFANSCV5DOVFAN2026-11-05
10198956377486CARDINAL HEALTHSOP42AAJCGSOP42AAJCG2026-11-05
10198956390423CARDINAL HEALTHSOP34ARBCLSOP34ARBCL2026-11-05
10198956391123CARDINAL HEALTHSBAX3FFOHASBAX3FFOHA2026-11-05
10198956391666CARDINAL HEALTHSEY69BPZEBSEY69BPZEB2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956396135CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956551381CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956572591CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956583801CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956584945CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956586710CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956589865CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956590106CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956591066CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956595835CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956605244CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956610149CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956614161CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956616622CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956618534CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956619210CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956621459CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956622210CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956623170CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956624658CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956624795CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10198956627581CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-05
10809160543726HALYARDMEDICAL ACTION INDUSTRIES INC.FDE2026-11-04
10198956627840CARDINAL HEALTHCardinal Health 200, LLCFDE2026-11-03
B098AMS4331D0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-30
10198956503519CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-29
10198956611627CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-29
10198956549524CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-23
10198956575172CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956589940CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19