FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956292015
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
OTC
false
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

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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
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