FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106807185
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN24ENOX2
Catalog number
SEN24ENOX2
Device description
ENT PACK
Published
2024-10-22
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
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
50197106807185PackageGS14In Commercial Distribution
10197106807187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710680718550197106807185
1019710680718710197106807187

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.

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
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
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS12206A0Aligned Medical SolutionsAligned Medical SolutionsOGR2026-09-18
10198956463394CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956503397CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956519534CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956535848CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956540804CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956545540CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956546943CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956547605CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956556270CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956557260CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956560277CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956562394CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956568792CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956569133CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956570320CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956571631CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956573086CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956573093CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956409767CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956502697CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956548336CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956551725CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956557703CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956562134CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956562233CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956563803CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956564565CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956463738CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-18
10198956416598CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17