FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956325166
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-8427C
Catalog number
03-8427C
Device description
UNIVERSAL TRAY
Published
2026-03-10
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
PPDUniversal drainage tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPDUniversal Drainage TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956325164PackageGS136In Commercial Distribution
10198956325166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895632516450198956325164
1019895632516610198956325166

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.

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450486993Merit Medical®Merit Medical Systems, Inc.PPD2026-06-09
00884450110270Merit Drainage Depot™Merit Medical Systems, Inc.PPD2026-06-06
00884450467183Merit Medical®Merit Medical Systems, Inc.PPD2026-06-02
00884450487679Merit Medical®Merit Medical Systems, Inc.PPD2026-05-28
00884450111185Merit Medical®Merit Medical Systems, Inc.PPD2026-05-02
00884450112120Merit Medical®Merit Medical Systems, Inc.PPD2026-02-25
00884450111109Merit Medical®Merit Medical Systems, Inc.PPD2026-02-20
00884450111857Merit Medical®Merit Medical Systems, Inc.PPD2026-02-14
00884450112090Merit Medical®Merit Medical Systems, Inc.PPD2026-02-05
00884450112540Merit Medical®Merit Medical Systems, Inc.PPD2026-01-27
00884450113240Merit Medical®Merit Medical Systems, Inc.PPD2026-01-20
00884450112267Merit Medical®Merit Medical Systems, Inc.PPD2026-01-03
00884450113479Merit Medical®Merit Medical Systems, Inc.PPD2026-01-03
00884450034002Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
00884450108758Merit Medical®Merit Medical Systems, Inc.PPD2025-12-18
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00884450108499Merit Medical®Merit Medical Systems, Inc.PPD2025-12-16
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00884450105474Merit Medical®Merit Medical Systems, Inc.PPD2025-11-27
00884450105849Merit Medical®Merit Medical Systems, Inc.PPD2025-11-27
00884450034057Merit Medical®Merit Medical Systems, Inc.PPD2025-11-22
00884450034071Merit Medical®Merit Medical Systems, Inc.PPD2025-11-06
00884450034385Merit Medical®Merit Medical Systems, Inc.PPD2025-10-28
00884450102077Merit Medical®Merit Medical Systems, Inc.PPD2025-10-28
00884450033258Merit Medical®Merit Medical Systems, Inc.PPD2025-09-23
00884450033241Merit Medical®Merit Medical Systems, Inc.PPD2025-09-20
00884450034026Merit Medical®Merit Medical Systems, Inc.PPD2025-09-12
00884450033494Merit Medical®Merit Medical Systems, Inc.PPD2025-08-08
00884450093399Merit Medical®Merit Medical Systems, Inc.PPD2025-06-13