FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106955468
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-8093B
Catalog number
34-8093B
Device description
ANESTHESIA SPINAL TRAY
Published
2025-03-11
Public version status
New
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
OFUSpinal anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106955466PackageGS120In Commercial Distribution
10197106955468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710695546650197106955466
1019710695546810197106955468

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
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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956381100CARDINAL HEALTHCardinal Health 200, LLCOFU2026-08-18
10198956465718CARDINAL HEALTHCardinal Health 200, LLCOFU2026-07-06
10198956507159CARDINAL HEALTHCardinal Health 200, LLCOFU2026-06-23
10198956444461CARDINAL HEALTHCardinal Health 200, LLCOFU2026-05-08
10198956457812CARDINAL HEALTHCardinal Health 200, LLCOFU2026-05-04
10198956444362CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-21
10198956407107CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-14
10198956359833CARDINAL HEALTHCardinal Health 200, LLCOFU2026-04-06
10198956359321CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
10198956406803CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
10198956421172CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
10198956393349CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-19
10198956364622CARDINAL HEALTHCardinal Health 200, LLCOFU2026-02-09
10198956238732CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
10198956343603CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
10198956270749CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-29
10198956266513CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
10198956248595CARDINAL HEALTHCardinal Health 200, LLCOFU2025-11-06
10198956139978CARDINAL HEALTHCardinal Health 200, LLCOFU2025-10-13
10198956124639CARDINAL HEALTHCardinal Health 200, LLCOFU2025-10-03
10198956169593CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
10198956133693CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
10198956099630CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-20
10198956080652CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
10197106924136CARDINAL HEALTHCardinal Health 200, LLCOFU2025-04-03
10198956009653CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-31
10198956007246CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-25
10197106980248CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-14
10197106839355CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-10
10197106938515CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-28