FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956258549
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
08-8880B
Catalog number
08-8880B
Device description
ER LACERATION TRAY
Published
2025-12-11
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
PKDLaceration tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKDLaceration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956258547PackageGS128In Commercial Distribution
10198956258549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895625854750198956258547
1019895625854910198956258549

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

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
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
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956193611CARDINAL HEALTHCardinal Health 200, LLCPKD2026-02-17
10198956269521CARDINAL HEALTHCardinal Health 200, LLCPKD2026-01-15
10198956272422CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-19
10198956274327CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-09
10198956281493CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-09
10198956161832CARDINAL HEALTHCardinal Health 200, LLCPKD2025-11-25
10198459475177MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-18
10198459467455MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-11
10198459426209MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-04
10198459437960MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-04
10198459350924MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459424427MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459437854MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459440311MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459442155MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459432422MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-21
10198459432590MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-21
10198956099371CARDINAL HEALTHCardinal Health 200, LLCPKD2025-07-21
10198459400230MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-07
10198459389337MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-02
10198459391613MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-02
10198956104181CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-26
10198459333491MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459369735MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459370199MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459375637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459379086MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198956042117CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-11
10198956071797CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-09
10198459333187MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-05-02