FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106386200
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA23OBGT9
Catalog number
SMA23OBGT9
Device description
OB PROCEDURE PACK
Published
2023-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106386208PackageGS12In Commercial Distribution
10197106386200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710638620850197106386208
1019710638620010197106386200

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528402HalyardAVID MEDICAL, INC.OKV2026-08-03
10809160528471HalyardAVID MEDICAL, INC.OKV2026-08-03
10198956531307CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956534094CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956536999CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10809160528075HalyardAVID MEDICAL, INC.OKV2026-07-29
10809160527856HalyardAVID MEDICAL, INC.OKV2026-07-28
10198956499263CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10198956510937CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-27
10809160527702HalyardAVID MEDICAL, INC.OKV2026-07-21
10198956532250CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-20
10809160527542HalyardAVID MEDICAL, INC.OKV2026-07-20
10809160527382HalyardAVID MEDICAL, INC.OKV2026-07-17
10809160527498HalyardAVID MEDICAL, INC.OKV2026-07-17
10198956486584CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-16
10809160527269HalyardAVID MEDICAL, INC.OKV2026-07-16
10198956388208CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-09
10809160526927HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526941HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526842HalyardAVID MEDICAL, INC.OKV2026-07-08
10809160526811HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526828HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526507HalyardAVID MEDICAL, INC.OKV2026-07-06
10809160526309HalyardAVID MEDICAL, INC.OKV2026-06-26
10809160525951HalyardAVID MEDICAL, INC.OKV2026-06-24
10198956485075CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-23
10809160525203HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525258HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525265HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525326HalyardAVID MEDICAL, INC.OKV2026-06-22