FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594085023
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV21ENEUA
Catalog number
SCV21ENEUA
Device description
UNQ ENDO PACK
Published
2021-05-26
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
FZPCLIP, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594085023PackageGS1115In Commercial Distribution
10195594085025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559408502350195594085023
1019559408502510195594085025

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34026704921394WECKTELEFLEX INCORPORATEDFZP2026-01-13
24026704921328WECKTELEFLEX INCORPORATEDFZP2025-08-25
24026704725308WECKTELEFLEX INCORPORATEDFZP2025-07-03
44026704613869WECKTELEFLEX INCORPORATEDFZP2025-05-13
44026704613876WECKTELEFLEX INCORPORATEDFZP2025-05-13
34026704613848WECKTELEFLEX INCORPORATEDFZP2025-04-28
44026704613852WECKTELEFLEX INCORPORATEDFZP2025-04-24
44026704933608WECKTELEFLEX INCORPORATEDFZP2025-04-24
44026704933639WECKTELEFLEX INCORPORATEDFZP2025-04-24
34026704933663WECKTELEFLEX INCORPORATEDFZP2025-04-24
44026704912627WECKTELEFLEX INCORPORATEDFZP2025-04-04
44026704912634WECKTELEFLEX INCORPORATEDFZP2025-04-04
34026704922971WECKTELEFLEX INCORPORATEDFZP2025-04-04
10844735006381ZIPCLIPSYNOVIS MICRO COMPANIES ALLIANCE, INCFZP2025-03-04
44026704933301WECKTELEFLEX INCORPORATEDFZP2024-11-15
00842180152748ELMEDELMED INCORPORATEDFZP2024-06-18
24026704725261WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725275WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725282WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725292WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725315WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725322WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725339WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725346WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725353WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725360WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725459WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725469WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725476WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725480WECKTELEFLEX INCORPORATEDFZP2024-03-13