FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956548435
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT53CYSUA
Catalog number
SOT53CYSUA
Device description
CYSTO PACK
Published
2026-08-26
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956548433PackageGS14In Commercial Distribution
10198956548435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654843350198956548433
1019895654843510198956548435

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.

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956522596CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956535589CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956537644CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956552111CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956571679CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956573666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956530355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548206CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548213CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956549258CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956549562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956550186CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956561168CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956563582CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956543973CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956548107CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956556409CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956558830CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956542211CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-17
10809160528358HALYARDAVID MEDICAL, INC.NWU2026-08-01
10198956441842CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956509511CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539174CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27