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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956569416CARDINAL HEALTHCardinal Health 200, LLCPVY2026-10-15
10198956569393CARDINAL HEALTHCardinal Health 200, LLCPVY2026-10-12
10198956570023CARDINAL HEALTHCardinal Health 200, LLCPVY2026-09-29
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