FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956587861
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
AMN2228772
Catalog number
AMN2228772
Device description
KIT, ADMISSION
Published
2026-09-21
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
50198956587869PackageGS142In Commercial Distribution
10198956587861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658786950198956587869
1019895658786110198956587861

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816611026649AngioSystems TrayANGIOSYSTEMS, INCORPORATEDLRP2026-09-22
10198956446953CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956486294CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956520240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956570191CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578371CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956579644CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588042CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588868CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588875CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589070CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589148CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589155CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589483CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956589636CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956590342CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956591561CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592834CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956592995CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593312CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956593329CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594067CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594456CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594463CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956594708CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956588585CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-21