FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956060449
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PECGETRO9
Catalog number
PECGETRO9
Device description
KIT, ROC MYRINGOTOMY
Published
2025-04-25
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
50198956060447PackageGS11In Commercial Distribution
10198956060449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895606044750198956060447
1019895606044910198956060449

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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

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
10198956079984CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
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
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956060447CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25