FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956529823
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT69CTJ22
Catalog number
SOT69CTJ22
Device description
CYSTO PACK
Published
2026-07-20
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
50198956529821PackageGS12In Commercial Distribution
10198956529823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895652982150198956529821
1019895652982310198956529823

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 Temperature00

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964153877Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964153921Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964153976Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964154089Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964154096Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
10198956366251CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956456952CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956469761CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956508415CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956509542CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956515666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956531260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956532304CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956532618CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956532762CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956495067CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956502789CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956518056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956527232CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956528963CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956457768CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956465749CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956486065CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956491939CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956508286CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956512382CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956526686CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956527621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956528260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956481435CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-06