FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106784394
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA43DBT14
Catalog number
SBA43DBT14
Device description
DR BOYER ACCESSORY PACK
Published
2024-10-01
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
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106784394PackageGS14In Commercial Distribution
10197106784396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710678439450197106784394
1019710678439610197106784396

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
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
true
No natural rubber latex
false
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
20809160515157MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-03-05
50198956254730CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
50198956369359CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956410815CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
50198956377477CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
50198956318388CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
20809160509750MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-01-21
50198956325133CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
50198956201840CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956299977CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
50198956285710CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
50198956249866CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956250053CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
50198956192964CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
50198956199628CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956279795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
50198956241846CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
50198956284560CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956284676CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
50198956233520CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
50198956185126CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
50198956192889CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22
20809160494896Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-19
50198956132311CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-04
20809160493585Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-04
20809160493257Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OVN2025-09-02
50198956170795CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-19
50198956160345CARDINAL HEALTHCardinal Health 200, LLCOVN2025-08-05
50198956150131CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-28
50198956132083CARDINAL HEALTHCardinal Health 200, LLCOVN2025-07-11