FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956190878
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT45VPEAI
Catalog number
SOT45VPEAI
Device description
VASECTOMY PACK
Published
2025-09-29
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
50198956190878PackageGS18In Commercial Distribution
10198956190870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895619087850198956190878
1019895619087010198956190870

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.

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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956466821CARDINAL HEALTHCardinal Health 200, LLCPVY2026-05-19
10198956421875CARDINAL HEALTHCardinal Health 200, LLCPVY2026-04-27
10198956293915CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-30
50198956293913CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-30
10198956292260CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-22
50198956292268CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-22
10198956268043CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-15
50198956268041CARDINAL HEALTHCardinal Health 200, LLCPVY2026-01-15
10198956235601CARDINAL HEALTHCardinal Health 200, LLCPVY2025-10-28
10198956204478CARDINAL HEALTHCardinal Health 200, LLCPVY2025-10-23
10198956143340CARDINAL HEALTHCardinal Health 200, LLCPVY2025-10-03
10198956190870CARDINAL HEALTHCardinal Health 200, LLCPVY2025-09-29
10198956134386CARDINAL HEALTHCardinal Health 200, LLCPVY2025-08-29
50198956134384CARDINAL HEALTHCardinal Health 200, LLCPVY2025-08-29
10198956128767CARDINAL HEALTHCardinal Health 200, LLCPVY2025-07-29
50198956128765CARDINAL HEALTHCardinal Health 200, LLCPVY2025-07-29
10198956103177CARDINAL HEALTHCardinal Health 200, LLCPVY2025-07-02
50198956103175CARDINAL HEALTHCardinal Health 200, LLCPVY2025-07-02
10197106995020CARDINAL HEALTHCardinal Health 200, LLCPVY2025-03-27
50197106995028CARDINAL HEALTHCardinal Health 200, LLCPVY2025-03-27
10197106916872CARDINAL HEALTHCardinal Health 200, LLCPVY2025-02-21
50197106916870CARDINAL HEALTHCardinal Health 200, LLCPVY2025-02-21
10197106910757CARDINAL HEALTHCardinal Health 200, LLCPVY2025-01-29
10197106816288CARDINAL HEALTHCardinal Health 200, LLCPVY2024-12-11
50197106816286CARDINAL HEALTHCardinal Health 200, LLCPVY2024-12-11
10197106747520CARDINAL HEALTHCardinal Health 200, LLCPVY2024-10-02
50197106747528CARDINAL HEALTHCardinal Health 200, LLCPVY2024-10-02
10197106754214CARDINAL HEALTHCardinal Health 200, LLCPVY2024-09-17
50197106754212CARDINAL HEALTHCardinal Health 200, LLCPVY2024-09-17
00817405024117iScreen™ Instant Technologies, Inc.PVY2024-08-06