FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956079984
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN15PMR15
Catalog number
SEN15PMR15
Device description
PEDS MYRINGOTOMY PACK
Published
2025-05-21
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
OGSMyringotomy procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956079982PackageGS120In Commercial Distribution
10198956079984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895607998250198956079982
1019895607998410198956079984

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956374195CARDINAL HEALTHCardinal Health 200, LLCOGS2026-04-14
10198956403369CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
10198956358874CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956369054CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956317628CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
10198956261679CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
10198956223479CARDINAL HEALTHCardinal Health 200, LLCOGS2025-10-23
10198956180819CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
10198956132733CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
10198956111936CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
10198956117242CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
10197106858844CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
10198956060364CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
10197106988398CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
10198956060449CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956060447CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25