CARDINAL HEALTH

Primary DI
10197106627310
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBACGLPFMA
Catalog number
SBACGLPFMA
Device description
GENERAL LAPAROSCOPY PACK
Published
2024-05-16
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
FAAREPLACER, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAAReplacer, UrethralUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106627318PackageGS14In Commercial Distribution
10197106627310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662731850197106627318
1019710662731010197106627310

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 Temperature15 Degrees Celsius30 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
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
10197106805589CARDINAL HEALTHCardinal Health 200, LLCFAA2024-12-04
50197106805587CARDINAL HEALTHCardinal Health 200, LLCFAA2024-12-04
50197106627318CARDINAL HEALTHCardinal Health 200, LLCFAA2024-05-16
10197106528716CARDINAL HEALTHCardinal Health 200, LLCFAA2024-02-08
50197106528714CARDINAL HEALTHCardinal Health 200, LLCFAA2024-02-08