FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594156075
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN29DOME7
Catalog number
SEN29DOME7
Device description
DENTAL ORAL PACK
Published
2021-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594156075PackageGS16In Commercial Distribution
10195594156077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559415607550195594156075
1019559415607710195594156077

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956539785CARDINAL HEALTHCardinal Health 200, LLCOJV2026-09-25
10198956338661CARDINAL HEALTHCardinal Health 200, LLCOJV2026-09-22
10198956542389CARDINAL HEALTHCardinal Health 200, LLCOJV2026-09-21
10198956582903CARDINAL HEALTHCardinal Health 200, LLCOJV2026-09-21
10198956530591CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-27
10198956528659CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-20
10198956400856CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-16
10198956515215CARDINAL HEALTHCardinal Health 200, LLCOJV2026-07-06
10198956457898CARDINAL HEALTHCardinal Health 200, LLCOJV2026-06-01
10195594797751CARDINAL HEALTHCardinal Health 200, LLCOJV2023-08-02
10197106059609CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-19
10197106162712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-07-05
10197106163962CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-14
10197106229132CARDINAL HEALTHCardinal Health 200, LLCOJV2023-06-05
10197106221785CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106236727CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-31
10197106170540CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-18
10197106188712CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-11
10197106110263CARDINAL HEALTHCardinal Health 200, LLCOJV2023-05-02
10197106220146CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-21
10197106226667CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-20
10197106229484CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106234334CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106240816CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-19
10197106154281CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106182659CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-07
10197106056516CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106136508CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106196533CARDINAL HEALTHCardinal Health 200, LLCOJV2023-04-05
10197106175644CARDINAL HEALTHCardinal Health 200, LLCOJV2023-03-29