FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425401772
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN48TNHAI
Catalog number
SEN48TNHAI
Device description
STERILE TONSIL PACK
Published
2016-08-29
Public version status
Update
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
50885425401770PackageGS15In Commercial Distribution
10885425401772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542540177050885425401770
1088542540177210885425401772

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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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