FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594957612
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN13ASB14
Catalog number
SAN13ASB14
Device description
ASPIRATION TRAY
Published
2021-03-08
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
OJTAspiration tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJTAspiration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594957610PackageGS16In Commercial Distribution
10195594957612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559495761050195594957610
1019559495761210195594957612

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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956383265CARDINAL HEALTHCardinal Health 200, LLCOJT2026-04-28
10198956458642CARDINAL HEALTHCardinal Health 200, LLCOJT2026-04-27
10198956408098CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-23
10198956391956CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-19
10198956164017CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
10198956338555CARDINAL HEALTHCardinal Health 200, LLCOJT2026-03-02
10198956387393CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-23
10198956368040CARDINAL HEALTHCardinal Health 200, LLCOJT2026-02-13
10198956276017CARDINAL HEALTHCardinal Health 200, LLCOJT2025-12-09
10198956162525CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-19
10198956262782CARDINAL HEALTHCardinal Health 200, LLCOJT2025-11-13
10198956240209CARDINAL HEALTHCardinal Health 200, LLCOJT2025-10-23
10198956170087CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-11
10198956163867CARDINAL HEALTHCardinal Health 200, LLCOJT2025-08-05
10198956112117CARDINAL HEALTHCardinal Health 200, LLCOJT2025-07-28
10198956110076CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-13
10198956099746CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-10
10198956086517CARDINAL HEALTHCardinal Health 200, LLCOJT2025-06-05
10198956015913CARDINAL HEALTHCardinal Health 200, LLCOJT2025-03-31
10197106970621CARDINAL HEALTHCardinal Health 200, LLCOJT2025-02-26
10197106884096CARDINAL HEALTHCardinal Health 200, LLCOJT2025-01-13
10197106848500CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-25
10197106817445CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
10197106821213CARDINAL HEALTHCardinal Health 200, LLCOJT2024-11-07
10197106782309CARDINAL HEALTHCardinal Health 200, LLCOJT2024-10-03
10197106755471CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-30
10197106755099CARDINAL HEALTHCardinal Health 200, LLCOJT2024-08-28
10197106723432CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-26
10197106718179CARDINAL HEALTHCardinal Health 200, LLCOJT2024-07-16
10197106683156CARDINAL HEALTHCardinal Health 200, LLCOJT2024-06-18