FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425298136
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE23LMCDE
Catalog number
SNE23LMCDE
Device description
STERILE LAMINECTOMY PACK
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50885425298134PackageGS12In Commercial Distribution
10885425298136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542529813450885425298134
1088542529813610885425298136

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 Temperature040 Degrees Celsius

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106896327CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956489165CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956491625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956492141CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956502581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956518384CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526501CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956527553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528185CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528437CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528727CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10809160526897HalyardAVID MEDICAL, INC.OJG2026-07-08
10198956416079CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956502062CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956515536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956524873CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956525344CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956527348CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10809160526187HalyardAVID MEDICAL, INC.OJG2026-06-25
10809160526194HalyardAVID MEDICAL, INC.OJG2026-06-25
10809160525999HalyardAVID MEDICAL, INC.OJG2026-06-24
10809160526040HalyardAVID MEDICAL, INC.OJG2026-06-24
10198956340169CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956365674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956491120CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956502796CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956512085CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956512825CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23
10198956513808CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-23