FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956190870
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
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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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
50198956190878CARDINAL 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