FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956128682
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT7NPISAA
Catalog number
SOT7NPISAA
Device description
PENILE IMPLANT PACK
Published
2025-07-29
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
50198956128680PackageGS13In Commercial Distribution
10198956128682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895612868050198956128680
1019895612868210198956128682

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

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
10198956292017CARDINAL HEALTHCardinal Health 200, LLCQGA2026-01-22
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
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