FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594085070
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SCV21OHEUA
Catalog number
SCV21OHEUA
Device description
UNQ OPEN HEART PACK
Published
2021-06-04
Public version status
Update
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
GAOSuture, nonabsorbable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAOSuture, NonabsorbableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594085078PackageGS151In Commercial Distribution
10195594085070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559408507850195594085078
1019559408507010195594085070

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
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
20885380214377KendallCB2LCB2L2026-10-12
20885380214384KendallCB2LITECB2LITE2026-10-12
20885380214391KendallCB2XLCB2XL2026-10-12
20885380214407KendallCB3LCB3L2026-10-12
20885380214414KendallCB4LCB4L2026-10-12
10192253046397Kendall55535PAMD55535PAMD2023-09-27
10192253046762Kendall55588BAMD55588BAMD2023-10-09
10885380173691Curity6309G6309G2019-11-14
20192253039358Kerlix458845882025-03-19
20192253039365Kerlix50425042-2025-03-19
20192253039372Kerlix61206120-2025-03-19
20192253039396Kerlix507250722025-03-19
20192253039594Kerlix258525852025-03-19
20885380173490Curity2556G2556G2019-11-14
20885380173513Curity2835G2835G2019-11-14
20192253008347CARDINAL HEALTH5005005005002020-09-24
20192253016632Kendall222002A222002A-2024-02-28
20192253016830Kendall30710001307100012024-02-28
20192253017813KendallEF00149EF001492024-02-28
20885380130950MEDI-VAC65652-11965652-1192018-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841291102069Myo/Wire IIA & E MEDICAL CORPORATIONGAO2018-07-25
10841291102281Myo/Wire IIA & E MEDICAL CORPORATIONGAO2018-05-08
10841291102106Myo/Wire IIA & E MEDICAL CORPORATIONGAO2016-01-13
10841291101727Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291101932Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291102113Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291102212Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-18
10841291101093Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101109Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101116Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101123Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101130Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101147Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101154Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101161Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101178Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101185Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101192Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101208Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101215Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101222Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101239Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101246Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101253Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101260Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101277Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101284Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101291Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101307Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15
10841291101314Myo/Wire IIA & E MEDICAL CORPORATIONGAO2015-09-15