FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106758267
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
END403092A
Catalog number
END403092A
Device description
KIT, ENDO
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106758265PackageGS130In Commercial Distribution
10197106758267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710675826550197106758265
1019710675826710197106758267

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141588225750Carnegie Surgical LLCCarnegie Surgical LLCLRP2026-10-07
00810017915293Saber-XA, Trial CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915309SABER-XA, Screw CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915316SABER-XA, Cage & Plate Caddy, 34Wx26DELEVATION SPINE, INC.LRP2026-10-06
00810017915323SABER-XA, Cage & Plate Caddy, 37Wx28DELEVATION SPINE, INC.LRP2026-10-06
00810017915330SABER-XA, Cage & Plate Caddy, 40Wx30DELEVATION SPINE, INC.LRP2026-10-06
00810017915347SABER-XA, Spike CaddyELEVATION SPINE, INC.LRP2026-10-06
10198956339156CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956552340CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956584990CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956591660CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956592162CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956603684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604605CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604698CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605756CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605831CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956606050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956606302CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956608917CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956498914CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599437CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599574CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956601581CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956370487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956539235CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956560406CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956578586CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956585065CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956587236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29