FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956127386
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17B4392D
Catalog number
17B4392D
Device description
VASECTOMY PACK
Published
2025-07-07
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
KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956127386PackageGS114In Commercial Distribution
10198956127388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895612738650198956127386
1019895612738810198956127388

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
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
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25
00190776408459MillenniumAvalign Technologies, Inc.KOA2025-08-11
00190776408121MillenniumAvalign Technologies, Inc.KOA2025-08-06
00198506084416ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084430ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084447ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084454ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05