FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594130099
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT31CYSG3
Catalog number
SOT31CYSG3
Device description
CYSTO PACK
Published
2021-06-02
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
50195594130099PackageGS13In Commercial Distribution
10195594130091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559413009950195594130099
1019559413009110195594130091

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. 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.

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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956364349CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956408739CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956428775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956474673CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482272CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956482562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956489684CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956496309CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498037CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956498600CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956499164CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-08
10198956367630CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956379855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956431669CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956469976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956482036CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956485655CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956492837CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956496590CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956499454CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-05
10198956482791CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-03
10198956332102CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956372610CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956388598CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956394643CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956397712CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956448278CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956464322CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956469020CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956475786CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01