FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956488069
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA13VHCO9
Catalog number
SMA13VHCO9
Device description
VAGINAL HYSTERECTOMY
Published
2026-06-01
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
50198956488067PackageGS13In Commercial Distribution
10198956488069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648806750198956488067
1019895648806910198956488069

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956492103CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956492363CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956496330CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956498389CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956525504CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956526020CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL 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