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

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
20885380213851CARDINAL HEALTHCH33225CH332252026-11-02
10192253025316Monoject888151123588815112352021-09-17
20884521014999Monoject888151131088815113102016-09-24
20884521014937Monoject888151111088815111102016-09-24
10192253046526Kendall55546BAMD55546BAMD2023-10-09
10192253046786Kendall55588BAMDX55588BAMDX2025-09-09
10885380031687PROTEXIS2D72NT65X2D72NT65X2018-04-13
10192253025309Monoject888151120188815112012021-09-17
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29

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