FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106523643
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA4JGLWLA
Catalog number
SBA4JGLWLA
Device description
GENERAL LAPAROSCOPY PACK
Published
2024-01-24
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
FDAEnteroscope and accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106523641PackageGS14In Commercial Distribution
10197106523643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710652364150197106523641
1019710652364310197106523643

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04547410491715FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
04547410514056FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
50197106523641CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
10197106447185CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
50197106447183CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
10860006600805AncoraAspero Medical, Inc.FDA2023-10-26
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04547410463439FUJIFILMFUJIFILM CORPORATIONFDA2022-01-30
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04953170165740STOPPEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165764PROBE HANGEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
06934955960246Jade PTA Balloon Dilatation CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.FDA2020-12-25
00052569143735HealthMart STRATEGIC SOURCING SERVICES LLCFDA2020-07-31
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00075289122811ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
70075289122810ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
04547410384536FUJIFILMFUJIFILM CORPORATIONFDA2019-07-04
00811503033316Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27
10811503033306Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27