FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106545164
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP45CPCUA
Catalog number
SOP45CPCUA
Device description
CYSTO PACK
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50197106545162PackageGS14In Commercial Distribution
10197106545164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710654516250197106545162
1019710654516410197106545164

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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253024456Argyle888472450488847245042026-10-09
10192253024463Argyle888825860888882586082026-10-09
10192253050783Argyle888686430488868643042026-10-09
10192253050790Argyle888686460488868646042026-10-09
10192253050806Argyle888825736088882573602026-10-09
10192253050813Argyle888825737888882573782026-10-09
10192253050820Argyle888825738688882573862026-10-09
10192253050837Argyle888825746988882574692026-10-09
10192253050844Argyle888825747788882574772026-10-09
10192253050851Argyle888825748588882574852026-10-09
10192253050868Argyle888825752788882575272026-10-09
10192253050875Argyle888825753588882575352026-10-09
10192253050882Argyle888825755088882575502026-10-09
10885380214813DermaceaWD6112WD61122026-10-09
10885380214820DermaceaWD6113WD61132026-10-09
10885380214837DermaceaWD6114WD61142026-10-09
10885380214844DermaceaWD6115WD61152026-10-09
10885380214851DermaceaWD6116WD61162026-10-09
20885380157339FLEXAL88RT01XS88RT01XS2018-09-21
20885380157346FLEXAL88RT02S88RT02S2018-09-21

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
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
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