FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956587489
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE53NMO27
Catalog number
SNE53NMO27
Device description
SOR NEURO MINOR PACK
Published
2026-09-22
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956587487PackageGS12In Commercial Distribution
10198956587489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658748750198956587487
1019895658748910198956587489

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
10809160538951HalyardAVID MEDICAL, INC.OJG2026-09-24
10198956313897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956488366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956489196CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956502123CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956505902CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956521070CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956541450CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956550322CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956568051CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956569232CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956570450CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956570788CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956581685CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956581913CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956582217CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956582347CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956583610CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956583627CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956585133CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956585393CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956585881CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956587670CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956533615CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21
10198956578616CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21
10198956579521CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21
10198956580824CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21
10198956582873CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21
10198956583498CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21
10198956583672CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-21