FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106289914
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ORC566411A
Catalog number
ORC566411A
Device description
KIT, TURNOVER
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PWUClean-up kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWUClean-Up KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106289912PackageGS124In Commercial Distribution
10197106289914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710628991250197106289912
1019710628991410197106289914

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818634020635Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025210Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025838Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634026040Bosma EnterprisesBosma EnterprisesPWU2026-05-14
00818634025807Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634025821Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634025890Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026019Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026026Bosma EnterprisesBosma EnterprisesPWU2026-04-14
00818634026033Bosma EnterprisesBosma EnterprisesPWU2026-04-14
10197106978825CARDINAL HEALTHCardinal Health 200, LLCPWU2025-10-03
10198956020054CARDINAL HEALTHCardinal Health 200, LLCPWU2025-03-14
50198956020052CARDINAL HEALTHCardinal Health 200, LLCPWU2025-03-14
10197106754795CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
50197106754793CARDINAL HEALTHCardinal Health 200, LLCPWU2024-09-24
00818634025531Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025586Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025593Bosma EnterprisesBosma EnterprisesPWU2024-03-15
00818634025524Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025538Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025583Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10818634025590Bosma EnterprisesBosma EnterprisesPWU2024-03-15
10304040167974Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
00304040167977Henry ScheinHENRY SCHEIN, INC.PWU2023-07-30
50197106289912CARDINAL HEALTHCardinal Health 200, LLCPWU2023-06-15
M75257014920STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-04-05
M75257027820STRADIS HEALTHCARESTRADIS MEDICAL, LLCPWU2022-03-10
10195594555733CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03
50195594555731CARDINAL HEALTHCardinal Health 200, LLCPWU2022-03-03
10195594539177CARDINAL HEALTHCardinal Health 200, LLCPWU2022-02-18