FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956292017
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT54PIUAA
Catalog number
SOT54PIUAA
Device description
PENILE IMPLANT PACK
Published
2026-01-22
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
QGAPenile implant surgical accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGAPenile Implant Surgical AccessoriesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956292015PackageGS13In Commercial Distribution
10198956292017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895629201550198956292015
1019895629201710198956292017

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 Temperature15 Degrees Celsius30 Degrees Celsius

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
Contains natural rubber latex
true

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
10198956416789CARDINAL HEALTHCardinal Health 200, LLCQGA2026-04-21
10198956437012CARDINAL HEALTHCardinal Health 200, LLCQGA2026-04-09
10198956340510CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-23
50198956340518CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-23
10198956289710CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-19
50198956289718CARDINAL HEALTHCardinal Health 200, LLCQGA2026-03-19
10198956101609CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-26
50198956101607CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-26
50198956292015CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-22
10198956252929CARDINAL HEALTHCardinal Health 200, LLCQGA2025-12-10
50198956252927CARDINAL HEALTHCardinal Health 200, LLCQGA2025-12-10
10198956265189CARDINAL HEALTHCardinal Health 200, LLCQGA2025-11-17
50198956265187CARDINAL HEALTHCardinal Health 200, LLCQGA2025-11-17
10198956206328CARDINAL HEALTHCardinal Health 200, LLCQGA2025-10-20
10198956136281CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-22
50198956136289CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-22
10198956165373CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
10198956167193CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
50198956165371CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
50198956167191CARDINAL HEALTHCardinal Health 200, LLCQGA2025-08-11
10198956128682CARDINAL HEALTHCardinal Health 200, LLCQGA2025-07-29
50198956128680CARDINAL HEALTHCardinal Health 200, LLCQGA2025-07-29
00850033207811RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207828RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207842RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00850033207873RIGICON DILATOM™ Rigicon, Inc.QGA2024-06-26
00850033207880RIGICON DILATOM™Rigicon, Inc.QGA2024-06-26
00191506022181FurlowBOSTON SCIENTIFIC CORPORATIONQGA2022-11-18
00878953005386SizerBOSTON SCIENTIFIC CORPORATIONQGA2017-03-31
00878953000176Furlow Insertion ToolBOSTON SCIENTIFIC CORPORATIONQGA2014-09-25