FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439340136
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN23BKCM1
Catalog number
SEN23BKCM1
Device description
DISCOGRAM PACK
Published
2019-01-10
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
OILDiscography kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OILDiscography KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439340134PackageGS110In Commercial Distribution
10888439340136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843934013450888439340134
1088843934013610888439340136

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 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
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
10198956235823CARDINAL HEALTHCardinal Health 200, LLCOIL2025-10-23
10197106922514CARDINAL HEALTHCardinal Health 200, LLCOIL2025-05-29
50197106922512CARDINAL HEALTHCardinal Health 200, LLCOIL2025-05-29
10197106551417CARDINAL HEALTHCardinal Health 200, LLCOIL2024-07-16
50197106551415CARDINAL HEALTHCardinal Health 200, LLCOIL2024-07-16
10197106518984CARDINAL HEALTHCardinal Health 200, LLCOIL2024-02-07
50197106518982CARDINAL HEALTHCardinal Health 200, LLCOIL2024-02-07
10197106533628CARDINAL HEALTHCardinal Health 200, LLCOIL2024-01-17
50197106533626CARDINAL HEALTHCardinal Health 200, LLCOIL2024-01-17
B875550Discography KitCustom Interventional Pain Management, LLCOIL2023-07-19
B87555LID0Discography KitCustom Interventional Pain Management, LLCOIL2023-07-19
10888439854107CARDINAL HEALTHCardinal Health 200, LLCOIL2020-07-06
50888439854105CARDINAL HEALTHCardinal Health 200, LLCOIL2020-07-06
10888439679953CARDINAL HEALTHCardinal Health 200, LLCOIL2020-02-04
50888439679951CARDINAL HEALTHCardinal Health 200, LLCOIL2020-02-04
10888439423938CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-18
50888439423936CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-18
10888439401455CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-01
50888439401453CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-01
10888439345902CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-24
50888439345900CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-24
10888439312836CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-22
50888439312834CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-22
50888439340134CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-10
10888439246643CARDINAL HEALTHCardinal Health 200, LLCOIL2018-10-26
50888439246641CARDINAL HEALTHCardinal Health 200, LLCOIL2018-10-26
10887488712840CARDINAL HEALTHCardinal Health 200, LLCOIL2017-05-17
50887488712848CARDINAL HEALTHCardinal Health 200, LLCOIL2017-05-17
10887488221786CARDINAL HEALTHCardinal Health 200, LLCOIL2016-09-26
50887488221784CARDINAL HEALTHCardinal Health 200, LLCOIL2016-09-26