FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106995028
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17A4014C
Catalog number
17A4014C
Device description
VASECTOMY PACK
Published
2025-03-27
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
PVYVasovasostomy Set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVYVasovasostomy SetGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106995028PackageGS117In Commercial Distribution
10197106995020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710699502850197106995028
1019710699502010197106995020

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. 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 urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any 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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956293913CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-30
50198956292268CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-22
50198956268041CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-15
50198956190878CARDINAL HEALTHCardinal Health 200, LLCPVY2025-09-29
50198956134384CARDINAL HEALTHCardinal Health 200, LLCPVY2025-08-29
50198956128765CARDINAL HEALTHCardinal Health 200, LLCPVY2025-07-29
50198956103175CARDINAL HEALTHCardinal Health 200, LLCPVY2025-07-02
50197106916870CARDINAL HEALTHCardinal Health 200, LLCPVY2025-02-21
50197106816286CARDINAL HEALTHCardinal Health 200, LLCPVY2024-12-11
50197106747528CARDINAL HEALTHCardinal Health 200, LLCPVY2024-10-02
50197106754212CARDINAL HEALTHCardinal Health 200, LLCPVY2024-09-17
50197106627394CARDINAL HEALTHCardinal Health 200, LLCPVY2024-05-02
50197106481279CARDINAL HEALTHCardinal Health 200, LLCPVY2024-03-11
50197106550784CARDINAL HEALTHCardinal Health 200, LLCPVY2024-02-21
50197106490899CARDINAL HEALTHCardinal Health 200, LLCPVY2023-12-28
50197106084074CARDINAL HEALTHCardinal Health 200, LLCPVY2023-06-05
50197106248698CARDINAL HEALTHCardinal Health 200, LLCPVY2023-04-28
50197106249237CARDINAL HEALTHCardinal Health 200, LLCPVY2023-04-24
50197106103881CARDINAL HEALTHCardinal Health 200, LLCPVY2023-03-10
50197106123889CARDINAL HEALTHCardinal Health 200, LLCPVY2023-02-03
50195594760012CARDINAL HEALTHCardinal Health 200, LLCPVY2022-12-05
50195594899828CARDINAL HEALTHCardinal Health 200, LLCPVY2022-11-03
50197106014811CARDINAL HEALTHCardinal Health 200, LLCPVY2022-11-02
50195594845139CARDINAL HEALTHCardinal Health 200, LLCPVY2022-10-13
50195594695987CARDINAL HEALTHCardinal Health 200, LLCPVY2022-06-21
50195594641199CARDINAL HEALTHCardinal Health 200, LLCPVY2022-06-01
M75288825490STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVY2022-03-17
50195594366856CARDINAL HEALTHCardinal Health 200, LLCPVY2021-10-27
50195594063939CARDINAL HEALTHCardinal Health 200, LLCPVY2021-06-03
50195594957030CARDINAL HEALTHCardinal Health 200, LLCPVY2021-03-24