FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956299979
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER23ERI16
Catalog number
SER23ERI16
Device description
ER SUTURE TRAY
Published
2025-12-29
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
OVNSuture kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956299977PackageGS110In Commercial Distribution
10198956299979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895629997750198956299977
1019895629997910198956299979

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956037908CARDINAL HEALTHCardinal Health 200, LLCOVN2026-09-04
14026704724106DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704725066DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704725073DEKNATELTELEFLEX INCORPORATEDOVN2026-08-01
14026704724120DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
14026704724182DEKNATELTELEFLEX INCORPORATEDOVN2026-07-29
10809160528006MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-07-28
10809160523155MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OVN2026-06-09
10198956258662CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956381131CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956299528CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-09
10198956308206CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-06
10198956254732CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
10198956369351CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956410817CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956377479CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
10198956318380CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
10198956325135CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
10198956252134CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956299511CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956201842CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956285712CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
10198956249868CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956250055CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956192966CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
10198956199620CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956279797CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25