FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106814053
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT43CYMUA
Catalog number
SOT43CYMUA
Device description
CYSTO PACK
Published
2024-11-22
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
50197106814053PackageGS14In Commercial Distribution
10197106814055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710681405350197106814053
1019710681405510197106814055

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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106824481CARDINAL HEALTHCardinal Health 200, LLCNAA2024-12-13
50197106824489CARDINAL HEALTHCardinal Health 200, LLCNAA2024-12-13
10197106814055CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-22
10197106782514CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-06
50197106782512CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-06
10197106778890CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-01
50197106778898CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-01
10197106743126CARDINAL HEALTHCardinal Health 200, LLCNAA2024-09-24
50197106743124CARDINAL HEALTHCardinal Health 200, LLCNAA2024-09-24
10197106764107CARDINAL HEALTHCardinal Health 200, LLCNAA2024-09-09
50197106764105CARDINAL HEALTHCardinal Health 200, LLCNAA2024-09-09
10197106680674CARDINAL HEALTHCardinal Health 200, LLCNAA2024-05-31
50197106680672CARDINAL HEALTHCardinal Health 200, LLCNAA2024-05-31
10197106582497CARDINAL HEALTHCardinal Health 200, LLCNAA2024-03-28
50197106582495CARDINAL HEALTHCardinal Health 200, LLCNAA2024-03-28
10197106555675CARDINAL HEALTHCardinal Health 200, LLCNAA2024-02-14
50197106555673CARDINAL HEALTHCardinal Health 200, LLCNAA2024-02-14
10197106529003CARDINAL HEALTHCardinal Health 200, LLCNAA2024-02-07
50197106529001CARDINAL HEALTHCardinal Health 200, LLCNAA2024-02-07
10197106545164CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-31
50197106545162CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-31
10197106525210CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-29
50197106525218CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-29
10197106511695CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-03
50197106511693CARDINAL HEALTHCardinal Health 200, LLCNAA2024-01-03
10197106444986CARDINAL HEALTHCardinal Health 200, LLCNAA2023-10-23
50197106444984CARDINAL HEALTHCardinal Health 200, LLCNAA2023-10-23
10197106440100CARDINAL HEALTHCardinal Health 200, LLCNAA2023-10-19
50197106440108CARDINAL HEALTHCardinal Health 200, LLCNAA2023-10-19
10197106401132CARDINAL HEALTHCardinal Health 200, LLCNAA2023-09-14