FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106140930
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT23CSBU9
Catalog number
SOT23CSBU9
Device description
CYSTO PACK
Published
2023-02-10
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
NAALens, intraocular, accommodative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAALens, Intraocular, AccommodativeOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106140930PackageGS13In Commercial Distribution
10197106140932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710614093050197106140930
1019710614093210197106140932

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 Temperature15 Degrees Celsius30 Degrees Celsius

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50197106824489CARDINAL HEALTHCardinal Health 200, LLCNAA2024-12-13
50197106814053CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-22
50197106782512CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-06
50197106778898CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-01
50197106743124CARDINAL HEALTHCardinal Health 200, LLCNAA2024-09-24
50197106764105CARDINAL HEALTHCardinal Health 200, LLCNAA2024-09-09
50197106680672CARDINAL HEALTHCardinal Health 200, LLCNAA2024-05-31
50197106582495CARDINAL HEALTHCardinal Health 200, LLCNAA2024-03-28
50197106555673CARDINAL HEALTHCardinal Health 200, LLCNAA2024-02-14
50197106529001CARDINAL HEALTHCardinal Health 200, LLCNAA2024-02-07
50197106545162CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-31
50197106525218CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-29
50197106511693CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-03
50197106444984CARDINAL HEALTHCardinal Health 200, LLCNAA2023-10-23
50197106440108CARDINAL HEALTHCardinal Health 200, LLCNAA2023-10-19
50197106401130CARDINAL HEALTHCardinal Health 200, LLCNAA2023-09-14
50197106276646CARDINAL HEALTHCardinal Health 200, LLCNAA2023-08-18
50197106355518CARDINAL HEALTHCardinal Health 200, LLCNAA2023-07-25
50197106294879CARDINAL HEALTHCardinal Health 200, LLCNAA2023-07-11
50197106292660CARDINAL HEALTHCardinal Health 200, LLCNAA2023-06-20
50197106293872CARDINAL HEALTHCardinal Health 200, LLCNAA2023-06-15
50197106253128CARDINAL HEALTHCardinal Health 200, LLCNAA2023-05-03
50197106270330CARDINAL HEALTHCardinal Health 200, LLCNAA2023-05-03
50197106191178CARDINAL HEALTHCardinal Health 200, LLCNAA2023-03-29
50197106139125CARDINAL HEALTHCardinal Health 200, LLCNAA2023-02-24
50197106005987CARDINAL HEALTHCardinal Health 200, LLCNAA2022-12-02
50197106036080CARDINAL HEALTHCardinal Health 200, LLCNAA2022-11-18
50195594890863CARDINAL HEALTHCardinal Health 200, LLCNAA2022-10-20
50195594844798CARDINAL HEALTHCardinal Health 200, LLCNAA2022-09-26
50195594760166CARDINAL HEALTHCardinal Health 200, LLCNAA2022-09-09