FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106748792
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA73HPCPA
Catalog number
SMA73HPCPA
Device description
HYSTEROSCOPY PACK
Published
2024-09-11
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
OHAHeart valve, more than minimally manipulated allograft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHAHeart Valve, More Than Minimally Manipulated AllograftUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106748792PackageGS14In Commercial Distribution
10197106748794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710674879250197106748792
1019710674879410197106748794

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
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
10198956105799CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
10198956108752CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
50198956105797CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
50198956108750CARDINAL HEALTHCardinal Health 200, LLCOHA2025-06-10
10197106815731CARDINAL HEALTHCardinal Health 200, LLCOHA2024-11-01
50197106815739CARDINAL HEALTHCardinal Health 200, LLCOHA2024-11-01
10197106751695CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-25
50197106751693CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-25
10197106769836CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-08
50197106769834CARDINAL HEALTHCardinal Health 200, LLCOHA2024-10-08
10197106748787CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-19
50197106748785CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-19
10197106748794CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-11
10197106687888CARDINAL HEALTHCardinal Health 200, LLCOHA2024-07-03
50197106687886CARDINAL HEALTHCardinal Health 200, LLCOHA2024-07-03
10197106652541CARDINAL HEALTHCardinal Health 200, LLCOHA2024-06-15
50197106652549CARDINAL HEALTHCardinal Health 200, LLCOHA2024-06-15
10197106627860CARDINAL HEALTHCardinal Health 200, LLCOHA2024-05-16
50197106627868CARDINAL HEALTHCardinal Health 200, LLCOHA2024-05-16
10197106638620CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-17
50197106638628CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-17
10197106621042CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-10
50197106621040CARDINAL HEALTHCardinal Health 200, LLCOHA2024-04-10
10197106589458CARDINAL HEALTHCardinal Health 200, LLCOHA2024-03-28
50197106589456CARDINAL HEALTHCardinal Health 200, LLCOHA2024-03-28
10197106571835CARDINAL HEALTHCardinal Health 200, LLCOHA2024-02-14
50197106571833CARDINAL HEALTHCardinal Health 200, LLCOHA2024-02-14
10197106478479CARDINAL HEALTHCardinal Health 200, LLCOHA2024-01-09
10197106538753CARDINAL HEALTHCardinal Health 200, LLCOHA2024-01-09
10197106504321CARDINAL HEALTHCardinal Health 200, LLCOHA2024-01-08