FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106471300
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA5FRHM19
Catalog number
SMA5FRHM19
Device description
ROBOT HYSTERECTOMY
Published
2023-11-09
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
50197106471300PackageGS14In Commercial Distribution
10197106471302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710647130050197106471300
1019710647130210197106471302

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.

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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956464643CARDINAL HEALTHCardinal Health 200, LLCOJF2026-05-25
10198956481664CARDINAL HEALTHCardinal Health 200, LLCOJF2026-05-25
50198956326826CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956401004CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956402728CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956407648CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
50198956317527CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956376050CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956396317CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956413212CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-16
50198956402506CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-10
50198956393279CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-09
50198956220384CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956327984CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956401622CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956316612CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956320411CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956368826CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956394146CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956396980CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956335934CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956357721CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956358278CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956376524CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956380576CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956219371CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-13
50198956354256CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-13
50198956344684CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09
50198956346671CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09
50198956359398CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09