FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594397041
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA23YPDA4
Catalog number
SMA23YPDA4
Device description
HYSTEROSCOPY PACK
Published
2021-10-13
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594397041PackageGS110In Commercial Distribution
10195594397043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559439704150195594397041
1019559439704310195594397043

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
10193489212686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489212914Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489216318Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489217025Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413854Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489413960Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489419078Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489424027Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489424348Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425017Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425536Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489425611Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489428353Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489429619Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489430608Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489438529Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489441369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489443080Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489443868Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489444537Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489444841Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489444872Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489448719Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489454864Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489455380Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489456165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489456745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489457346Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08
10193489457391Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHD2023-06-08