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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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