FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106293874
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA2DDVCFK
Catalog number
SBA2DDVCFK
Device description
325320 DAVINCI II PACK
Published
2023-06-15
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
50197106293872PackageGS12In Commercial Distribution
10197106293874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710629387250197106293872
1019710629387410197106293874

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
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
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