FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439771112
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA11HYSB2
Catalog number
SMA11HYSB2
Device description
VAGINAL HYSTERECTOMY PACK
Published
2020-03-02
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
50888439771112PackageGS11In Commercial Distribution
10888439771114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843977111250888439771112
1088843977111410888439771114

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
10198956141018CARDINAL HEALTHSNEHFNSASASNEHFNSASA2026-10-06
10198956171954CARDINAL HEALTHSCVCGCVMHCSCVCGCVMHC2026-10-06
10198956286672CARDINAL HEALTHPOV20110MPOV20110M2026-10-06
10198956301511CARDINAL HEALTHSOPPDKRROCSOPPDKRROC2026-10-06
10198956306059CARDINAL HEALTHSOP51SHSRGSOP51SHSRG2026-10-06
10198956314351CARDINAL HEALTHSNE8BSPBPGSNE8BSPBPG2026-10-06
10198956339156CARDINAL HEALTHOR2224609BOR2224609B2026-10-06
10198956340268CARDINAL HEALTHSAN22IPMRDSAN22IPMRD2026-10-06
10198956348776CARDINAL HEALTHPL23CEMEFPL23CEMEF2026-10-06
10198956354494CARDINAL HEALTHSOPHFAPMRCSOPHFAPMRC2026-10-06
10198956362666CARDINAL HEALTHSOT54CPDRCSOT54CPDRC2026-10-06
10198956371019CARDINAL HEALTHSER5BCLHCCSER5BCLHCC2026-10-06
10198956379824CARDINAL HEALTHSOP21SAFECSOP21SAFEC2026-10-06
10198956391215CARDINAL HEALTHSANDHAGFHCSANDHAGFHC2026-10-06
10198956397859CARDINAL HEALTH34-9706C34-9706C2026-10-06
10198956399129CARDINAL HEALTH26-7824E26-7824E2026-10-06
10198956401846CARDINAL HEALTH34-3264R34-3264R2026-10-06
10198956402416CARDINAL HEALTHSOP13OHEXESOP13OHEXE2026-10-06
10198956420526CARDINAL HEALTHSAN4ATPJHCSAN4ATPJHC2026-10-06
10198956439535CARDINAL HEALTHSEN69ESKODSEN69ESKOD2026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570924CARDINAL HEALTHCardinal Health 200, LLCOJF2026-09-30
10198956558434CARDINAL HEALTHCardinal Health 200, LLCOJF2026-09-29
10198956544451CARDINAL HEALTHCardinal Health 200, LLCOJF2026-08-17
10198956342217CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-31
10197106886960CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956491090CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956535374CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956536647CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956423046CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956492127CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956515468CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956520288CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956492103CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956492363CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956496330CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956498389CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956525504CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956526020CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10198956488069CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10193489412796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413113Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489414783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489424249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489427813Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428483Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489430677Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489431650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08