FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488561301
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-4272A
Catalog number
34-4272A
Device description
PREP TRAY
Published
2016-08-02
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
OJWShave prep kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJWShave Prep KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488561309PackageGS125In Commercial Distribution
10887488561301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748856130950887488561309
1088748856130110887488561301

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 Temperature040 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956323216CARDINAL HEALTHCardinal Health 200, LLCOJW2026-02-12
10198956251137CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
50198956251135CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
10198956223905CARDINAL HEALTHCardinal Health 200, LLCOJW2025-10-28
10197106861271CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
50197106861279CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
10197106823378CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
50197106823376CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
10197106816233CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
50197106816231CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
10197106731208CARDINAL HEALTHCardinal Health 200, LLCOJW2024-08-05
50197106731206CARDINAL HEALTHCardinal Health 200, LLCOJW2024-08-05
10197106552353CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
50197106552351CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
10197106662984CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
50197106662982CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
10197106704004CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
50197106704002CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
10197106441541CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
50197106441549CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
10195594775384CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
50195594775382CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
10195594450755CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
50195594450753CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
10195594432317CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
50195594432315CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
10195594159412CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
50195594159410CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
10195594291242CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19
50195594291240CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19