FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439699973
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA5FABMM3
Catalog number
SBA5FABMM3
Device description
ABD HYSTERECTOMY PACK
Published
2020-02-04
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
OJFHysterectomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439699973PackageGS12In Commercial Distribution
10888439699975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843969997350888439699973
1088843969997510888439699975

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10198956488069CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10193489412796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413113Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489414783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489424249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489427813Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428483Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489430677Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489431650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489432688Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489448498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489450422Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-04-02
10193489950052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489432701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-06-05
10193489950298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489952810Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489987096Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-02-20
10193489950489Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-02-13
10193489950335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489950830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489952797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489955224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19