FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956584990
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
AMNOC4500C
Catalog number
AMNOC4500C
Device description
KIT, NYCHH ADMISSION
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
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
50198956584998PackageGS118In Commercial Distribution
10198956584990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658499850198956584998
1019895658499010198956584990

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.

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
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
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
10198956589018CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956589094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29