FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106687886
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA73HPVPA
Catalog number
SMA73HPVPA
Device description
HYSTEROSCOPY PACK
Published
2024-07-03
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
50197106687886PackageGS14In Commercial Distribution
10197106687888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710668788650197106687886
1019710668788810197106687888

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

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
50197106748792CARDINAL HEALTHCardinal Health 200, LLCOHA2024-09-11
10197106687888CARDINAL 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