FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594749040
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11CYHH4
Catalog number
SBA11CYHH4
Device description
CYSTO
Published
2022-07-06
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
NWUEndoscope introducer kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594749048PackageGS14In Commercial Distribution
10195594749040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559474904850195594749048
1019559474904010195594749040

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
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
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
10198956529823CARDINAL 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