FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106471324
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA12DCM15
Catalog number
SMA12DCM15
Device description
D AND C PK
Published
2023-10-23
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
HCYCURETTE, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106471324PackageGS13In Commercial Distribution
10197106471326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710647132450197106471324
1019710647132610197106471326

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
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
50198956419832CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-23
50198956405415CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-19
50198956322415CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-06
50198956389852CARDINAL HEALTHCardinal Health 200, LLCHCY2026-03-02
50198956331509CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-23
50198956377156CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-23
50198956326857CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-17
50198956340679CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-13
50198956344646CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-13
50198956326635CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-09
50198956329513CARDINAL HEALTHCardinal Health 200, LLCHCY2026-02-09
50198956311907CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-30
50198956291926CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-26
50198956317428CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-26
50198956141665CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-07
50198956267587CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-07
50198956289589CARDINAL HEALTHCardinal Health 200, LLCHCY2026-01-05
50198956289329CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-29
50198956302240CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-26
50198956268225CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-22
50198956325249CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-22
50198956290080CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-19
04046826068424MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHCY2025-12-17
50198956252675CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-17
50198956215465CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-11
50198956281248CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-11
50198956210811CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-09
50198956263985CARDINAL HEALTHCardinal Health 200, LLCHCY2025-12-09
50198956140637CARDINAL HEALTHCardinal Health 200, LLCHCY2025-11-25
50198956253528CARDINAL HEALTHCardinal Health 200, LLCHCY2025-11-25