FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594827120
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA21IRAU1
Catalog number
SBA21IRAU1
Device description
CUSTOM IRL PACK
Published
2022-10-03
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
OIORadiographic contrast tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIORadiographic Contrast TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594827128PackageGS16In Commercial Distribution
10195594827120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559482712850195594827128
1019559482712010195594827120

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 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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956514379CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-27
10198956530102CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-27
10198956533295CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-27
10198956529281CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-20
10198956470156CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-08
10198956470255CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-08
10198956418813CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-03
10198956496651CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-03
10198956369665CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-01
10197106083055CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-28
10197106065778CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-17
10197106083505CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-09
10197106074954CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-15
10197106047835CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-08
10197106061169CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-06
10197106044674CARDINAL HEALTHCardinal Health 200, LLCOIO2022-11-22
10195594793869CARDINAL HEALTHCardinal Health 200, LLCOIO2022-11-04
10197106015995CARDINAL HEALTHCardinal Health 200, LLCOIO2022-11-03
10197106007341CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-28
10197106002209CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-19
10195594790141CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-18
10195594874094CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594875398CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594876098CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594880156CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594845834CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-06
10195594531393CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-05
10195594835545CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-05
10195594810276CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-04
10195594870072CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-03