FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106824489
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTCGCYMHB
Catalog number
SOTCGCYMHB
Device description
CYSTO PACK
Published
2024-12-13
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
50197106824489PackageGS13In Commercial Distribution
10197106824481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710682448950197106824489
1019710682448110197106824481

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. 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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106824481CARDINAL HEALTHCardinal Health 200, LLCNAA2024-12-13
10197106814055CARDINAL HEALTHCardinal Health 200, LLCNAA2024-11-22
50197106814053CARDINAL 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