FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106747528
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT45VPUSA
Catalog number
SOT45VPUSA
Device description
VASECTOMY PACK
Published
2024-10-02
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
50197106747528PackageGS18In Commercial Distribution
10197106747520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710674752850197106747528
1019710674752010197106747520

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
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
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
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
10197106754214CARDINAL HEALTHCardinal Health 200, LLCPVY2024-09-17
50197106754212CARDINAL HEALTHCardinal Health 200, LLCPVY2024-09-17
00817405024117iScreen™ Instant Technologies, Inc.PVY2024-08-06