FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594938619
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAOCVPUC3
Catalog number
SMAOCVPUC3
Device description
VAGINAL PACK
Published
2021-02-12
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
50195594938619PackageGS14In Commercial Distribution
10195594938611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559493861950195594938619
1019559493861110195594938611

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.

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
10198956077348CARDINAL HEALTHSCV57RAKPQSCV57RAKPQ2026-10-12
10198956137547CARDINAL HEALTHPV35VKMBCPV35VKMBC2026-10-12
10198956194632CARDINAL HEALTHSAN33MPMPCSAN33MPMPC2026-10-12
10198956276437CARDINAL HEALTHSOPCNBERVBSOPCNBERVB2026-10-12
10198956301719CARDINAL HEALTHSOP53PKBSCSOP53PKBSC2026-10-12
10198956331259CARDINAL HEALTH32-1024F32-1024F2026-10-12
10198956333611CARDINAL HEALTHPOCGHNWTGPOCGHNWTG2026-10-12
10198956352230CARDINAL HEALTHSAN40SLRWBSAN40SLRWB2026-10-12
10198956361041CARDINAL HEALTHSOP44SPKSCSOP44SPKSC2026-10-12
10198956384439CARDINAL HEALTHSOP32LSISFSOP32LSISF2026-10-12
10198956388376CARDINAL HEALTHSOPCGTHOMESOPCGTHOME2026-10-12
10198956391239CARDINAL HEALTHSOT12CYMOCSOT12CYMOC2026-10-12
10198956399051CARDINAL HEALTHSUT44BPSCBSUT44BPSCB2026-10-12
10198956421240CARDINAL HEALTHSEY23CTRCPSEY23CTRCP2026-10-12
10198956460393CARDINAL HEALTHSEN30EEPRBSEN30EEPRB2026-10-12
10198956463875CARDINAL HEALTH02-0891H02-0891H2026-10-12
10198956471887CARDINAL HEALTHSCV54VCWMUSCV54VCWMU2026-10-12
10198956491298CARDINAL HEALTH31-1019F31-1019F2026-10-12
10198956493803CARDINAL HEALTHSNE11CR83GSNE11CR83G2026-10-12
10198956507425CARDINAL HEALTHSBA42BPSMBSBA42BPSMB2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956568365CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956574199CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956583139CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956587885CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956588226CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956601970CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956602793CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10809160540534HALYARDAVID MEDICAL, INC.OHD2026-10-12
10198956468733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956514539CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956558786CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956567658CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956569911CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956585034CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
B098AMS17355A0Aligned Medical SolutionsAligned Medical SolutionsOHD2026-10-05
10198956567832CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-30
10198956568334CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-30
10198956545335CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-29
10198956590120CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-29
10198956593978CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-29
B098AMS186920Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-26
10198956402522CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956485778CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956545953CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956547414CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956557109CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956567733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956570764CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956587991CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956333758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22