FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594782757
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN12NS336
Catalog number
SEN12NS336
Device description
SINUS ENDOSCOPY PACK
Published
2022-08-17
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594782755PackageGS13In Commercial Distribution
10195594782757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559478275550195594782755
1019559478275710195594782757

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.

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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
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
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956471863CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956477063CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956484283CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956492110CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956492714CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956519954CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956520271CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956524156CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956524774CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956525443CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956526228CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956526365CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956526587CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956526860CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956526877CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-09
10198956358942CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956389007CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956457157CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956468153CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956515833CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956526556CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956527164CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956527638CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-06
10198956458017CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-23
10198956482289CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-23
10198956511392CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-23
10198956514089CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-23
10197106983577CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956362932CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08
10198956386150CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-08