FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956538313
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PL23OT819
Catalog number
PL23OT819
Device description
KIT, C SECTION ADMIT BOX
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
50198956538311PackageGS11In Commercial Distribution
10198956538313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653831150198956538311
1019895653831310198956538313

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956516014CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956536043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
04046826380830Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826380939Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413187Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413194Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413200Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826438180Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495800Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495954Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
00198506092343ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-29
03661219268444LANDANGERLANDANGERLRP2026-07-29
00198506093739ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-28
00642356005812SteriBestMastel Surgical Inc.LRP2026-07-28
08057639712660Box AdapterMC BIO SRLLRP2026-07-28
10198956414419CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956488236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956489189CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956492745CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956493025CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956505117CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956509214CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513488CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513716CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513778CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956520035CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523609CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523821CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27