FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439291931
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA35CPSF2
Catalog number
SBA35CPSF2
Device description
CYSTO PACK 572
Published
2018-11-30
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
50888439291931PackageGS15In Commercial Distribution
10888439291933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843929193150888439291931
1088843929193310888439291933

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570733CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-30
10198956396906CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956552548CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568419CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956568518CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956574564CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956590526CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956593824CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956594074CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956595903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-29
10198956388239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956531697CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956568372CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956576759CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956587328CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956589131CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956590151CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956590489CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956590618CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956593138CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-25
10198956554283CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956557000CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956557390CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956558557CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956561205CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956578685CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956580893CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956581036CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956584075CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22
10198956585256CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-22